Atlas FDA

ENZYME-LINKED FLUORESCENT IMMUNOASSAY

FDA 510(k) clearance K943811 · decided 1994-11-02

Clearance details

K-number
K943811
Device name
ENZYME-LINKED FLUORESCENT IMMUNOASSAY
Applicant
Biomerieux Vitek, Inc.
Decision
Substantially Equivalent
Date received
1994-08-05
Decision date
1994-11-02
Days to decision
89 days
Clearance type
Traditional
Product code
CFT
Device class
1
Regulation number
862.1625
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Rockland, MA, 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
PROLACTIN (PRL) HORMONE MICROPLATE ELISA (K971921)Monobind1997-06-24
VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS (K970281)Johnson & Johnson Clinical Diagnostics, Inc.1997-02-25
SEALITE SCIENCES, INC. AQUALITE PROLACTIN (K970188)Sealite Sciences, Inc.1997-02-20
ELECSYS PROLACTIN ASSAY (K964748)Boehringer Mannheim Corp.1997-01-21
DSL ACTIVE PROLACTIN ELISA MODEL 10-4500 (K960561)Diagnostic Systems Laboratories, Inc.1996-04-26
DSL ACTIVE PROLACTIN IRMA (K960060)Diagnostic Systems Laboratories, Inc.1996-02-29
ACCESS PROLACTIN ASSAY (MODIFICATION) (K954680)Bio-Rad Laboratories, Inc.1995-10-20
ABBOTT IMX PROLACTIN(MODIFICATION) (K953656)Abbott Mfg., Inc.1995-10-03
ABBOTT AXSYM PROLACTIN(MODIFICATION) (K953657)Abbott Mfg., Inc.1995-09-25
AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1 (K944698)Organon Teknika Corp.1995-03-21
AXSYM PROLACTIN (K935675)Abbott Laboratories1994-06-21
DUPONT ACA PLUS PROLACTIN (PROL) METHOD (K941220)Dupont Medical Products1994-06-03

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
VITEK 2 SYSTEM, MODELS VITEK 2 AND VITEK 2 XL (N50510/S146)Biomerieux Vitek, Inc.2001-10-17
VITEK 2 GRAM POSITIVE AST PANEL FOR STREPTOCOCCUS PNEUMONIAE: TRIMETHOPRIM/SULFAMETHOXAZOLE (N50510/S145)Biomerieux Vitek, Inc.2001-06-25
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR GATIFLOXACIN (N50510/S143)Biomerieux Vitek, Inc.2001-06-13
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR QUINUPRISTIN/DALFOPRISTIN (N50510/S144)Biomerieux Vitek, Inc.2001-06-13
VITEK GRAM POSITIVE AST FOR MOXIFLOXACIN (N50510/S142)Biomerieux Vitek, Inc.2001-05-30
VITEK 2 GRAM POSITIVE AST FOR SPARFLOXACIN (N50510/S141)Biomerieux Vitek, Inc.2001-05-14
VITEK(R) 2 GRAM POSITIVE AST FOR MINOCYCLINE (N50510/S140)Biomerieux Vitek, Inc.2001-03-09
VITEK 2 GRAM POSITIVE AST FOR VANCOMYCIN (N50510/S138)Biomerieux Vitek, Inc.2000-08-11