GIARDEIA(TM)— 510(k) K890774

Substantially Equivalent

Antibodies, Inc.

FDA 510(k) clearance K890774 for GIARDEIA(TM), Substantially Equivalent on 1989-04-04. Applicant: Antibodies, Inc.. Device class: 2.

Clearance details

Applicant: Antibodies, Inc.
Product code: Code KHW
Device class: Class 2
Regulation: 21 CFR 866.3220
Advisory panel: Microbiology
Date received: 1989-02-15
Decision date: 1989-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Davis, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KHW

K170728 — E. HISTOLYTICA QUIK CHEK2017-06-07
K994101 — E. HISTOLYTICA II1999-12-21
K955895 — E. HISTOLYTICA TEST1996-08-30
K954996 — TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM1996-08-08
K944791 — ENTAMOEBA TEST1995-03-09

More clearances from Antibodies, Inc.

K843590 — DETECT-A-STREP1984-10-30
K822892 — CORTISOL RIA KIT1982-11-01
K812749 — ULTRA-DIG1981-10-19
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.