Atlas FDA

TANDEM - HGH KIT

FDA 510(k) clearance K821366 · decided 1982-06-10

Clearance details

K-number
K821366
Device name
TANDEM - HGH KIT
Applicant
Hybritech, Inc.
Decision
Substantially Equivalent
Date received
1982-05-10
Decision date
1982-06-10
Days to decision
31 days
Clearance type
Traditional
Product code
CFL
Device class
1
Regulation number
862.1370
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Mchenry, IL, 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
SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY (K972761)Sealite Sciences, Inc.1997-09-25
DSL ACTIVE NON-EXTRACTION IGF-I ELISA (K971353)Diagnostic Systems Laboratories, Inc.1997-05-12
DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900) (K970701)Diagnostic Systems Laboratories, Inc.1997-04-02
DSL 9100 IGF-II IRMA (K962758)Diagnostic Systems Laboratories, Inc.1996-08-30
HUMAN GROWTH HORMONE IMMUNOASSAY KIT (K961678)Nichols Institute Diagnostics1996-07-08
DSL ACTIVE NON-EXTRACTION IGF-I IRMA (K961172)Diagnostic Systems Laboratories, Inc.1996-04-23
DSL ACTIVE HUMAN GROWTH HORMONE ELISA (K960551)Diagnostic Systems Laboratories, Inc.1996-03-06
IMMULITE HGH (K955376)Diagnostic Products Corp.1996-02-16
INSULIN-LIKE GROWTH FACTOR-I (IGF-I) IMMUNORADIOMETRIC ASSAY (K955390)Corning Nichols Diagnostics1995-12-29
INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA) (K952505)Nichols Institute1995-07-03
IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3 (K946247)Nichols Institute1995-06-23
ACTIVE IGF-I ELISA (K951752)Diagnostic Systems Laboratories, Inc.1995-05-10

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