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510(k) K872678

IAFP THIOGLYCOLLATE W/O INDICATOR W/HEMIN&VITA. K1 by I.A.F. Production, Inc. — Product Code KZI

K872678 is an FDA 510(k) premarket notification submitted by I.A.F. Production, Inc. for the device "IAFP THIOGLYCOLLATE W/O INDICATOR W/HEMIN&VITA. K1". The FDA issued a decision of Substantially Equivalent on August 7, 1987. The device falls under product code KZI (Culture Media, Enriched), a Class I device regulated under 21 CFR 866.2330. I.A.F. Production, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1987
Date Received
July 7, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Enriched
Device Class
Class I
Regulation Number
866.2330
Review Panel
MI
Submission Type

Other clearances by I.A.F. Production, Inc.

  • K872690 — IAFP V. AGAR SELECTIVE (September 14, 1987)
  • K872692 — IAFP P.E.A. AGAR W/5% SHEEP BLOOD (August 11, 1987)
  • K872674 — IAFP COLUMBIA C.N.A. WITH 5% SHEEP BLOOD (August 11, 1987)
  • K872687 — IAFP MUELLER HINTON AGAR W/HEMO. W/CVA ENRICHMENT (August 11, 1987)
  • K872669 — IAFP X.L.D. AGAR (August 11, 1987)
  • K872681 — IAFP C.D.C. ANAEROBIC AGAR W/5% SHEEP BLOOD (August 11, 1987)
  • K872683 — IAFP BILE ESCULIN AGAR (August 11, 1987)
  • K872680 — IAFP HEKTOEN ENTERIC AGAR (August 11, 1987)
  • K872682 — IAFP S.S. AGAR (August 11, 1987)
  • K872672 — IAFP BILE ESCULIN AZIDE AGAR (August 11, 1987)

Other clearances for product code KZI

  • K884208 — LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION) (October 25, 1988)
  • K881995 — DIAMOND'S MEDIUM MODIFIED (June 2, 1988)
  • K880131 — LOWENSTEIN-JENSEN, GRUFT (March 31, 1988)
  • K880122 — MIDDLEBROOK 7H9 BROTH (March 31, 1988)
  • K880134 — MIDDLEBROOK 7H11 AGAR (March 31, 1988)
  • K880109 — CYSTINE TRYPTIC MEDIUM BASE (March 30, 1988)
  • K880138 — WALLENSTEIN MEDIUM SLANT (March 30, 1988)
  • K880127 — POTATO DEXTROSE AGAR (March 7, 1988)
  • K874179 — BIOTIS (TM) SABHI (DOUBLE POUR) (January 28, 1988)
  • K874177 — BIOTIS (TM) BCYE (December 4, 1987)

FDA data resources