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510(k) K931374

AFFIRM VPIII MICROBIAL IDENTIFICATION TEST by Microprobe Corp. — Product Code MLA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1993
Date Received
March 18, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dna Probe, Yeast
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

Other clearances by Microprobe Corp.

  • K931151 — AFFIRM(TM) VPIII MICROBIAL IDENT TEST FOR CANDIDA (June 18, 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)
  • K920536 — AFFIRM VP SAMPLE COLLECTION SET (July 30, 1992)

Other clearances for product code MLA

  • K931151 — AFFIRM(TM) VPIII MICROBIAL IDENT TEST FOR CANDIDA (June 18, 1993)