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510(k) K920536

AFFIRM VP SAMPLE COLLECTION SET by Microprobe Corp. — Product Code LIO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1992
Date Received
February 5, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Specimen Collection
Device Class
Class I
Regulation Number
866.2900
Review Panel
MI
Submission Type

Other clearances by Microprobe Corp.

  • K931151 — AFFIRM(TM) VPIII MICROBIAL IDENT TEST FOR CANDIDA (June 18, 1993)
  • K931374 — AFFIRM VPIII MICROBIAL IDENTIFICATION TEST (June 15, 1993)
  • K923133 — AFFIRM/VP IDENT.TEST G.VAGINALIS & T.VAGINALIS (September 25, 1992)
  • K922457 — AFFIRM VP MICROBIAL ID TEST FOR TRICHOMONAS VAGINA (September 25, 1992)
  • K923268 — AFFIRM PROCESSOR (July 30, 1992)

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