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510(k) K872670

IAFP MAC CONKEY AGAR by I.A.F. Production, Inc. — Product Code JSH

K872670 is an FDA 510(k) premarket notification submitted by I.A.F. Production, Inc. for the device "IAFP MAC CONKEY AGAR". The FDA issued a decision of Substantially Equivalent on August 11, 1987. The device falls under product code JSH (Culture Media, Non-Selective And Differential), a Class I device regulated under 21 CFR 866.2320. I.A.F. Production, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1987
Date Received
July 7, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Non-Selective And Differential
Device Class
Class I
Regulation Number
866.2320
Review Panel
MI
Submission Type

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

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

Other clearances for product code JSH

  • K881551 — PHENOL RED BROTH BASE (April 18, 1988)
  • K881486 — DNASE TEST AGAR (April 18, 1988)
  • K881553 — RUSSELL DOUBLE SUGAR AGAR (April 18, 1988)
  • K881559 — UREA AGAR BASE (April 18, 1988)
  • K881540 — FLO AGAR (April 18, 1988)
  • K881560 — UREA BROTH (April 18, 1988)
  • K880121 — MOELLERS DECARBOXYLASE, BASE (March 31, 1988)
  • K880117 — OF MEDIUM BASE (March 30, 1988)
  • K873270 — ACTINOMYCETE DIFFERENTIAL MEDIA (November 4, 1987)
  • K873263 — MAINTENANCE & CARBOHYDRATE FERMENTATION MEDIA (October 28, 1987)

FDA data resources