Atlas FDA

T-UPTAKE MICROPLATE EIA

FDA 510(k) clearance K980088 · decided 1998-02-04

Clearance details

K-number
K980088
Device name
T-UPTAKE MICROPLATE EIA
Applicant
Monobind
Decision
Substantially Equivalent
Date received
1998-01-09
Decision date
1998-02-04
Days to decision
26 days
Clearance type
Traditional
Product code
KHQ
Device class
2
Regulation number
862.1715
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Costa Mesa, CA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
ACE T UPTAKE REAGENT TU CALIBRATORS (K981375)Schiapparelli Biosystems, Inc.1998-06-10
CHIRON DIAGNOSTICS ACS:180TU P (K970539)Chiron Diagnostics Corp.1997-03-24
VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025) (K964308)Johnson & Johnson Clinical Diagnostics, Inc.1996-11-27
ELECSYS T-UPTAKE ASSAY (K961488)Boehringer Mannheim Corp.1996-06-12
CEDIA T UPTAKE ASSAY (K954807)Boehringer Mannheim Corp.1995-12-21
T-UPTAKE EIA TEST (K951586)Diagnostic Reagents, Inc.1995-05-15
STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY (K933414)Baxter Diagnostics, Inc.1994-11-22
AXSYM(TM) T-UPTAKE (K934312)Abbott Laboratories1994-06-21
VIDAS T UPTAKE (K935816)Biomerieux Vitek, Inc.1994-03-22
T3 UPTAKE CHEMILUMINESCENCE ASSAY (K926220)Nichols Institute Diagnostics1993-11-17
IQ TUPTAKE ASSAY (K931294)Becton Dickinson Advanced Diagnostics1993-07-22
COBAS(R)-FP REAGENTS FOR T-UPTAKE/CALIBRATORS (K926443)Roche Diagnostic Systems, Inc.1993-05-20

Recalls involving this device

No recalls on record reference this clearance.