MYCOPLASMA DETECTION KIT— 510(k) K771867

Name: FDA 510(k) clearance K771867
Creator: U.S. Food and Drug Administration
Published: 1977-11-17

Substantially Equivalent

Bioassay Systems Research Corp.

FDA 510(k) clearance K771867 for MYCOPLASMA DETECTION KIT, Substantially Equivalent on 1977-11-17. Applicant: Bioassay Systems Research Corp.. Device class: 1.

Clearance details

Applicant: Bioassay Systems Research Corp.
Product code: Code KPB
Device class: Class 1
Regulation: 21 CFR 864.2360
Advisory panel: Hematology
Date received: 1977-10-03
Decision date: 1977-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K781874 — MYCOPLASMA ARGININI FITC (30-403-41)1978-12-20
K781875 — STAIN KIT FOR CELL CULTURES (30-100-00)1978-12-20
K781390 — MYCOPLASMA HYORHINIS (BTS-7)1978-09-01

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K850990 — HFF GENCELLS1985-04-12
K780869 — CELL CULTURE LINES1978-08-14

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