FDA 510(k) Premarket Notification K971777: QUANTEX ASO-CRP-RF CONTROL

Submission Details & Decision

Normalized public record details for 510(k) notification K971777.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K971777

Applicant / Sponsor

Instrumentation Laboratory CO

Device Name

QUANTEX ASO-CRP-RF CONTROL

Product Code

JJT

Decision Date

1997-05-27

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Chemistry (CH)

Clearance Type

Traditional

Third Party Flag

Date Received

1997-05-14

Related Establishments / Registrations

VERICHEM LABORATORIES, INC. Registration: 1221645 View Registration
HELENA LABORATORIES, CORP. Registration: 1618982 View Registration
Bio-Rad Laboratories Inc. Registration: 2016706 View Registration
Alere San Diego, Inc. Registration: 2027969 View Registration
Diazyme Laboratories, Inc. Registration: 2032900 View Registration
CLINIQA CORPORATION Registration: 2085064 View Registration
MORE DIAGNOSTICS INC. Registration: 2085085 View Registration
RANDOX LABORATORIES LIMITED Registration: 3004493545 View Registration
ABBOTT LABORATORIES Registration: 3005333358 View Registration
Bio-Rad Laboratories Inc. Registration: 3010127294 View Registration
AALTO SCIENTIFIC LTD. Registration: 3011325031 View Registration
SHINO-TEST CORPORATION Registration: 3012240236 View Registration
ASTORIA-PACIFIC, INC. Registration: 3050015 View Registration
WALLAC OY Registration: 8043909 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610126 View Registration
BIOKIT S.A. Registration: 9610746 View Registration

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