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510(k) K771867

MYCOPLASMA DETECTION KIT by Bioassay Systems Research Corp. — Product Code KPB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 1977
Date Received
October 3, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media And Components, Mycoplasma Detection
Device Class
Class I
Regulation Number
864.2360
Review Panel
PA
Submission Type

Other clearances by Bioassay Systems Research Corp.

  • K850990 — HFF GENCELLS (April 12, 1985)
  • K780869 — CELL CULTURE LINES (August 14, 1978)

Other clearances for product code KPB

  • K781875 — STAIN KIT FOR CELL CULTURES (30-100-00) (December 20, 1978)
  • K781874 — MYCOPLASMA ARGININI FITC (30-403-41) (December 20, 1978)
  • K781390 — MYCOPLASMA HYORHINIS (BTS-7) (September 1, 1978)