FDA Device Registration & Listing · Nanjing Jiangsu, CN · Registration 3015505238
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| KXG | Applicator, Absorbent Tipped, Sterile | General Hospital | Class 1 | 880.6025 | 2019-10-11 |
| IBL | Microscope, Inverted Stage, Tissue Culture | Pathology | Class 1 | 864.3600 | 2019-10-11 |
| JRQ | Shaker/Stirrer | Clinical Chemistry | Class 1 | 862.2050 | 2019-10-11 |
| FNY | Basin, Emesis | General Hospital | Class 1 | 880.6730 | 2019-10-11 |
| JRB | Micro Mixer | Clinical Chemistry | Class 1 | 862.2050 | 2019-10-11 |
| LDZ | Fixative, Alcohol Containing | Pathology | Class 1 | 864.4010 | 2019-10-11 |
| KEW | Slides, Microscope | Pathology | Class 1 | 864.3010 | 2019-10-11 |
| JRO | Blender/Mixer | Clinical Chemistry | Class 1 | 862.2050 | 2019-10-11 |
| KXF | Applicator, Absorbent Tipped, Non-Sterile | General Hospital | Class 1 | 880.6025 | 2019-10-11 |
| IDW | Dispensers, Paraffin | Pathology | Class 1 | 864.3010 | 2019-10-11 |
| KJA | Flask, Tissue Culture | Hematology | Class 1 | 864.2240 | 2019-10-11 |
| IDZ | Cassettes, Tissue | Pathology | Class 1 | 864.3010 | 2019-10-11 |
| KJC | Bottle, Roller, Tissue Culture | Hematology | Class 1 | 864.2240 | 2019-10-11 |
| KIY | Chamber, Slide Culture | Hematology | Class 1 | 864.2240 | 2019-10-11 |
| IBK | Microscope, Fluorescence/U.V. | Pathology | Class 1 | 864.3600 | 2019-10-11 |
| IBJ | Light, Microscope | Pathology | Class 1 | 864.3600 | 2019-10-11 |
| JSG | Culture Media, Non-Selective And Non-Differential | Microbiology | Class 1 | 866.2300 | 2020-08-07 |
| GHC | Tube, Sedimentation Rate | Hematology | Class 1 | 864.6700 | 2019-10-11 |
| QMC | Transport Medium, Notified Per The Vtm Guidance | Microbiology | Class 1 | 866.2390 | 2021-03-26 |
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | Clinical Chemistry | Class 1 | 862.2050 | 2019-10-11 |
| LCN | Scraper, Tongue | Dental | Class 1 | 872.6855 | 2019-10-11 |
| GJW | Pipette, Pasteur | Hematology | Class 1 | 864.6160 | 2019-10-11 |
| NNK | Container, Specimen Mailer And Storage, Non-Sterile | Pathology | Class 1 | 864.3250 | 2019-10-11 |
| KET | Filters, Cell Collection, Tissue Processing | Pathology | Class 1 | 864.3010 | 2019-10-11 |
| LDY | Fixative, Formalin-Containing | Pathology | Class 1 | 864.4010 | 2019-10-11 |
| KEO | Formulations, Paraffin, All | Pathology | Class 1 | 864.4010 | 2025-04-04 |
| NNI | Container, Specimen, Non-Sterile | Pathology | Class 1 | 864.3250 | 2019-10-11 |
| HYL | Hematoxylin Mayer'S | Hematology | Class 1 | 864.1850 | 2019-10-11 |
| FMH | Container, Specimen, Sterile | Pathology | Class 1 | 864.3250 | 2019-10-11 |
| JSM | Culture Media, Non-Propagating Transport | Microbiology | Class 1 | 866.2390 | 2020-09-10 |
| GHK | Centrifuge, Microsedimentation | Hematology | Class 1 | 864.5350 | 2019-10-11 |
| HYB | Eosin Y | Hematology | Class 1 | 864.1850 | 2019-10-11 |
| FMA | Depressor, Tongue, Non-Surgical | General Hospital | Class 1 | 880.6230 | 2019-10-11 |
| JRC | Micro Pipette | Clinical Chemistry | Class 1 | 862.2050 | 2019-10-11 |
| KIZ | Dish, Tissue Culture | Hematology | Class 1 | 864.2240 | 2019-10-11 |
| JRL | Unit, Filter, Membrane | Clinical Chemistry | Class 1 | 862.2050 | 2019-10-11 |
No official correspondent registered.
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K761138 | Zeus Scientific, Inc. | FA TISSUE FIXATIVE & WASH SET | 1978-01-06 |
| K842913 | E K Ind., Inc. | WRIGHT STAIN FIXATIVE | 1984-09-07 |
| K880142 | Hardy Media | TSA W/LEC. & TWEEN. 80 | 1988-03-30 |
| K914894 | Microtest | VIRAPURE, CHLAMYPURE AND MYCOPURE | 1991-12-18 |
| K812750 | Instrumentation Laboratory CO | IL 703, STAT SEPARATOR | 1982-01-26 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0012-2015 | Richard-Allan Scientific Company | 1 | Protocol 10% NBF
Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue. |
| Z-0013-2015 | Richard-Allan Scientific Company | 1 | Richard-Allan Scientific Specimen Transportation System.
Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue. |
| Z-0014-2015 | Richard-Allan Scientific Company | 1 | Richard-Allan Scientific 10% Neutral Buffered Formalin.
Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue. |
| Z-0015-2015 | Richard-Allan Scientific Company | 1 | Richard-Allan Scientific Bio-Tite Specimen Containers.
Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue. |
| Z-0016-2015 | Richard-Allan Scientific Company | 1 | Richard-Allan Scientific 10% Neutral Buffered Formalin.
Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3032760064 | CARAN PRECISION ENGINEERING & MANUFACTURING CORP. | Brea, CA, US |
| 3014159736 | VIETNAM MEDICAL PLASTIC JSC | Tam Diep Ward Ninh Binh, VN |
| 3009656988 | STERIPACK USA (LIMITED) LLC | Lakeland, FL, US |
| 3010407203 | Sterigenics Italy SpA | Minerbio Bologna, IT |
| 3007344957 | Flextronics Manufacturing Juarez S. DE R.L. DE C.V. | Juarez Chihuahua, MX |
3015505238 when referencing this establishment in official correspondence.