Atlas FDA

TANDEM - EPRL

FDA 510(k) clearance K843804 · decided 1984-11-13

Clearance details

K-number
K843804
Device name
TANDEM - EPRL
Applicant
Hybritech, Inc.
Decision
Substantially Equivalent
Date received
1984-09-27
Decision date
1984-11-13
Days to decision
47 days
Clearance type
Traditional
Product code
CFT
Device class
1
Regulation number
862.1625
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
San Diego, 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
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
ENZYME-LINKED FLUORESCENT IMMUNOASSAY (K943811)Biomerieux Vitek, Inc.1994-11-02
AXSYM PROLACTIN (K935675)Abbott Laboratories1994-06-21

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
TANDEM(R) E CEA IMMUNORADIOMETRIC ASSAY (P840019/S012)Hybritech, Inc.1996-03-07
STRATUS (R) CEA FLUOROMETRIC ENZYME IMMUNOASSAY (P840019/S010)Hybritech, Inc.1994-03-17
TANDEM(R) R CEA IMMUNORADIOMETRIC ASSAY (P840019/S011)Hybritech, Inc.1994-01-13
TANDEM-R(R) CARCINOEMBRYONIC ANTIGEN (CEA) ASSAY (P840019/S009)Hybritech, Inc.1990-04-17
TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY (P840019/S008)Hybritech, Inc.1989-12-13
TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY (P840019/S007)Hybritech, Inc.1989-09-06
TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY (P840019/S006)Hybritech, Inc.1987-04-30
TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY (P840019/S005)Hybritech, Inc.1986-11-05