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510(k) K923133

AFFIRM/VP IDENT.TEST G.VAGINALIS & T.VAGINALIS by Microprobe Corp. — Product Code MJM

K923133 is an FDA 510(k) premarket notification submitted by Microprobe Corp. for the device "AFFIRM/VP IDENT.TEST G.VAGINALIS & T.VAGINALIS". The FDA issued a decision of Substantially Equivalent on September 25, 1992. The device falls under product code MJM (Dna Probe, Gardnerella Vaginalis), a Class I device regulated under 21 CFR 866.2660. Microprobe Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1992
Date Received
June 29, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dna Probe, Gardnerella Vaginalis
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)
  • K931374 — AFFIRM VPIII MICROBIAL IDENTIFICATION TEST (June 15, 1993)
  • K922457 — AFFIRM VP MICROBIAL ID TEST FOR TRICHOMONAS VAGINA (September 25, 1992)
  • K920536 — AFFIRM VP SAMPLE COLLECTION SET (July 30, 1992)
  • K923268 — AFFIRM PROCESSOR (July 30, 1992)

Other clearances for product code MJM

  • K964015 — INDICARD TEST (June 19, 1997)

FDA data resources