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510(k) K931241

FAST'N'FLAMMATORY KIT by Techlab, Inc. — Product Code GIA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1994
Date Received
March 11, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Leukocyte Peroxidase
Device Class
Class I
Regulation Number
864.7675
Review Panel
PA
Submission Type

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  • K173219 — CAMPYLOBACTER CHEK (January 22, 2018)
  • K173217 — CAMPYLOBACTER QUIK CHEK (January 22, 2018)
  • K171078 — TRI-COMBO PARASITE SCREEN (July 10, 2017)
  • K170728 — E. HISTOLYTICA QUIK CHEK (June 7, 2017)
  • K082499 — C. DIFF QUIK CHEK COMPLETE (March 26, 2009)
  • K053572 — C. DIFF QUIK CHEK (April 26, 2006)

Other clearances for product code GIA

  • K844402 — SIGMA PEROXIDASE MYELOPEROXIDASE STAINING PROCEDUR (January 4, 1985)
  • K811011 — HISTOCHEMICAL DEMONSTRATION OF LEUKOCYTE (May 15, 1981)