Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2531335

FEI Number

3001236673

Entity Name

Alltrista Plastics LLC

City/State/Country

Reedsville, PA, US

Establishment Address

20 Setar Way, Reedsville, PA 17084, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Alltrista Plastics LLC (Owner Number: 9056878)

Owner / Operator Contact Address

20 Setar Way, Reedsville, PA 17084, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

KOVA BVS100H KOVA-poc System Pack KOVA Slide II KOVA Glasstic Slide 10 with Grid KOVA Slide II with Grid KOVA Fast-Read 102 KOVA Glasstic Slide 10 KOVA Petter KOVA System Super Pac 1000 KOVA System Value Pac 500 KOVA KO-LEC-PAC KOVA System Pac II

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KEW	Slides, Microscope	Pathology	Class 1	864.3010	2021-04-30
JQW	Station, Pipetting And Diluting, For Clinical Use	Clinical Chemistry	Class 1	862.2750	2021-04-30
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2021-04-30

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Alltrista Plastics LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1063410	Alltrista Plastics LLC	Greer, SC, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K851403	Ventrex Laboratories, Inc.	VENTREZYME ALLERGEN DATA REDUCTION SYSTEM	1985-06-21
K761290	Nuclear Medical Laboratories, Inc.	COMPU-PET 300	1977-02-24
K770210	G.D. Searle and Co.	ANALYTIX AUTO SAMPLE PREP. STA. 1600	1977-02-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2013	Beckman Coulter Inc.	1	COULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus, is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
Z-0028-2012	Beckman Coulter Inc.	1	Coulter PrepPlus 2, Part Number: 378600, Serial Numbers: 1001008698, 1001008699, and 10018700. Coulter PrePlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.

Similar Registrations

Registration Number	Establishment Name	Location
2025606	CalibreScientific US, Inc.	VANCOUVER, WA, US
1000469910	Waldemar Knittel Glasbearbeitungs GmbH	BRAUNSCHWEIG, NIEDERSACHSEN Lower Saxony, DE
1417592	MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, US
8044093	Kolplast Ci Ltda	Itupeva Sao Paulo, BR
3008496560	NINGBO GREETMED MEDICAL INSTRUMENTS CO., LTD.	Ningbo Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2531335. Last updated year: 2026. Please use registration number 2531335 when referencing this establishment in official correspondence.