PARAMAX & GLUTAMYTRANSFERASE REAGENT— 510(k) K833001

Name: FDA 510(k) clearance K833001
Creator: U.S. Food and Drug Administration
Published: 1983-10-14

Substantially Equivalent

American Dade

FDA 510(k) clearance K833001 for PARAMAX & GLUTAMYTRANSFERASE REAGENT, Substantially Equivalent on 1983-10-14. Applicant: American Dade. Device class: 1.

Clearance details

Applicant: American Dade
Product code: Code JQB
Device class: Class 1
Regulation: 21 CFR 862.1360
Advisory panel: Clinical Chemistry
Date received: 1983-08-12
Decision date: 1983-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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K971466 — SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT)1997-05-06
K964457 — ROCHE COBAS IBTEGRA REAGENT CASSETTES1997-01-13
K964916 — GAMMA-GLUTAMYL TRANSPEPTIDASE1997-01-10

More clearances from American Dade

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K873051 — STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY1987-10-20
K873171 — STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY1987-09-29
K873052 — STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY1987-09-14
K872789 — PARAMAX URINE/CSF CALIBRATOR1987-09-02
K872195 — DATA-FI DIMERTEST LATEX ASSAY1987-08-06

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