PENASE— 510(k) K812877

Substantially Equivalent

Analytab Products, Inc.

FDA 510(k) clearance K812877 for PENASE, Substantially Equivalent on 1981-10-26. Applicant: Analytab Products, Inc.. Device class: 1.

Clearance details

Applicant: Analytab Products, Inc.
Product code: Code JTO
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1981-10-14
Decision date: 1981-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Analytab Products, Inc.

K912965 — API UNISCEPT KB1991-09-06
K912964 — API UNISCEPT MIC/UNISCEPT MICRO-MIC1991-08-29
K861408 — MODIFIED UNISCEPT KB LABELING AMENDMENT1986-05-16
K812862 — API GERM TUBE1981-10-26

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