IMMUNODOT LYME TEST— 510(k) K894410

Substantially Equivalent

General Biometrics, Inc.

FDA 510(k) clearance K894410 for IMMUNODOT LYME TEST, Substantially Equivalent on 1989-10-30. Applicant: General Biometrics, Inc.. Device class: 2.

Clearance details

Applicant: General Biometrics, Inc.
Product code: Code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1989-07-17
Decision date: 1989-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from General Biometrics, Inc.

K924843 — IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANEL1992-12-01
K920400 — IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) TEST1992-08-20
K920401 — IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST1992-08-20
K911627 — IMMUNODOT BORRELIA (LYME) TEST1992-04-08
K911599 — IMMUNOWELL LYME (P39 RECOMBINANT) TEST1991-12-30

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