ULTRA-DIG— 510(k) K812749

Substantially Equivalent

Antibodies, Inc.

FDA 510(k) clearance K812749 for ULTRA-DIG, Substantially Equivalent on 1981-10-19. Applicant: Antibodies, Inc.. Device class: 2.

Clearance details

Applicant: Antibodies, Inc.
Product code: Code LCS
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1981-09-29
Decision date: 1981-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K874748 — IMMPULSE DIGOXIN ASSAY REAGENTS1988-02-19

More clearances from Antibodies, Inc.

K890774 — GIARDEIA(TM)1989-04-04
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K822892 — CORTISOL RIA KIT1982-11-01
K812314 — CRITHIDNA ANTI-DNA TEST KIT1981-09-01
K802877 — AMIKACIN RIA KIT1980-12-19

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