Home / 510(k) Clearances / K872690

510(k) K872690

IAFP V. AGAR SELECTIVE by I.A.F. Production, Inc. — Product Code JSJ

K872690 is an FDA 510(k) premarket notification submitted by I.A.F. Production, Inc. for the device "IAFP V. AGAR SELECTIVE". The FDA issued a decision of Substantially Equivalent on September 14, 1987. The device falls under product code JSJ (Culture Media, Selective And Non-Differential), a Class I device regulated under 21 CFR 866.2360. I.A.F. Production, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1987
Date Received
July 7, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Selective And Non-Differential
Device Class
Class I
Regulation Number
866.2360
Review Panel
MI
Submission Type

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

  • K872689 — IAFP SABOURAUD DEXTROSE AGAR (August 11, 1987)
  • K872680 — IAFP HEKTOEN ENTERIC AGAR (August 11, 1987)
  • K872687 — IAFP MUELLER HINTON AGAR W/HEMO. W/CVA ENRICHMENT (August 11, 1987)
  • K872672 — IAFP BILE ESCULIN AZIDE 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)
  • K872683 — IAFP BILE ESCULIN AGAR (August 11, 1987)
  • K872692 — IAFP P.E.A. AGAR W/5% SHEEP BLOOD (August 11, 1987)
  • K872682 — IAFP S.S. AGAR (August 11, 1987)
  • K872688 — IAFP MUELLER HINTON AGAR W/5% SHEEP BLOOD (August 11, 1987)

Other clearances for product code JSJ

  • K882463 — POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421 (June 22, 1988)
  • K881561 — TERGITOL 7 BROTH (April 18, 1988)
  • K881524 — DERMATOPHYTE TEST MEDIUM (April 18, 1988)
  • K881565 — INHIBITORY MOLD AGAR (April 18, 1988)
  • K881578 — STREPTOSEL (April 18, 1988)
  • K881573 — PHYTONE YEAST EXTRACT AGAR (April 18, 1988)
  • K881544 — LITTMAN AGAR (April 18, 1988)
  • K881526 — CHAPMAN STONE MEDIUM (April 18, 1988)
  • K881571 — YM BROTH (April 18, 1988)
  • K881547 — MITIS SALIVARIUS AGAR (April 18, 1988)

FDA data resources