RUBEOLA TEST— 510(k) K884004

Substantially Equivalent

Gull Laboratories, Inc.

FDA 510(k) clearance K884004 for RUBEOLA TEST, Substantially Equivalent on 1988-12-05. Applicant: Gull Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Gull Laboratories, Inc.
Product code: Code GRE
Device class: Class 1
Regulation: 21 CFR 866.3520
Advisory panel: Microbiology
Date received: 1988-09-21
Decision date: 1988-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GRE

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K770687 — MEASLESVIRUS FLOURE. CONJUGATED ANTISERU1977-06-14

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