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510(k) K920536

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

K920536 is an FDA 510(k) premarket notification submitted by Microprobe Corp. for the device "AFFIRM VP SAMPLE COLLECTION SET". The FDA issued a decision of Substantially Equivalent on July 30, 1992. The device falls under product code LIO (Device, Specimen Collection), a Class I device regulated under 21 CFR 866.2900. Microprobe Corp. has at least 5 other 510(k) clearances on record.

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)
  • K922457 — AFFIRM VP MICROBIAL ID TEST FOR TRICHOMONAS VAGINA (September 25, 1992)
  • K923133 — AFFIRM/VP IDENT.TEST G.VAGINALIS & T.VAGINALIS (September 25, 1992)
  • K923268 — AFFIRM PROCESSOR (July 30, 1992)

Other clearances for product code LIO

  • K222613 — ARX Liquid Amies Collection & Transport System (March 27, 2024)
  • K131630 — PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM (October 21, 2013)
  • K120846 — TRANSPORT CULTURE MEDIUM DEVICE (June 8, 2012)
  • K103805 — MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION (January 25, 2011)
  • K082472 — VIROCULT, MODEL MW950 (December 30, 2008)
  • K070062 — COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL (July 30, 2007)
  • K013711 — BACTI-SWAB DRY (November 26, 2001)
  • K003761 — NAT - NUCLEIC ACID TRANSPORT (May 31, 2001)
  • K983119 — ENTERO-TEST HP, MODEL #102-01 (March 15, 1999)
  • K981391 — PAR-ONE (July 14, 1998)

FDA data resources