CYTOCLONE A & B EIA— 510(k) K911958

Substantially Equivalent

Cambridge Biotech Corp.

FDA 510(k) clearance K911958 for CYTOCLONE A & B EIA, Substantially Equivalent on 1991-07-30. Applicant: Cambridge Biotech Corp.. Device class: 1.

Clearance details

Applicant: Cambridge Biotech Corp.
Product code: Code LLH
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1991-05-03
Decision date: 1991-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Worcester, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLH

K193490 — SensiTox C. difficile Toxin Test2021-07-08
K102242 — OSOM C. DIFFICILE TOXIN A/B TEST2010-12-21
K091109 — XPERT C. DIFFICILE2009-07-09
K090239 — PROGASTRO CD ASSAY2009-04-16
K082499 — C. DIFF QUIK CHEK COMPLETE2009-03-26

More clearances from Cambridge Biotech Corp.

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