PROTEOLYTIC ENZYME CONTROL— 510(k) K803110

Substantially Equivalent

American Dade

FDA 510(k) clearance K803110 for PROTEOLYTIC ENZYME CONTROL, Substantially Equivalent on 1981-02-17. Applicant: American Dade. Device class: 2.

Clearance details

Applicant: American Dade
Product code: Code LGP
Device class: Class 2
Regulation: 21 CFR 864.5425
Advisory panel: Hematology
Date received: 1980-12-10
Decision date: 1981-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code LGP

K864213 — IL TEST 97572-15, ALPHA 2-ANTIPLASMIN ASSAY1986-11-25
K850411 — GEN. DIAG. CHROMOSTRATE ALPHA-2 ANTIPLASMIN ASSAY1985-05-08
K833890 — COATEST ANTIPLASMIN1984-01-30
K802840 — ALPHA-ANTIPLASM ASSAY1981-02-17

More clearances from American Dade

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.