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510(k) K875136

COLUMBIA BLOOD AGAR P3308/ COLUMBIA CNA P3750 by Lakewood Biochemical Co., Inc. — Product Code JSG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1988
Date Received
December 15, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Non-Selective And Non-Differential
Device Class
Class I
Regulation Number
866.2300
Review Panel
MI
Submission Type

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  • K882463 — POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421 (June 22, 1988)
  • K882182 — SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326 (June 6, 1988)
  • K880946 — NUTRIENT GELATIN - PRODUCT NUMBER T2860 (April 1, 1988)
  • K880947 — NUTRIENT AGAR PLATE, SLANT TUBE AND BROTH TUBE (April 1, 1988)
  • K880945 — CAMPLYOBACTER CULTURE MEDIA PRODUCTS P3873/T3597 (March 30, 1988)
  • K874537 — KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGAR (November 20, 1987)
  • K874538 — TODD-HEWITT BROTH (0.5ML)#3099 & (5.OML)#T3516 (November 20, 1987)
  • K874345 — TSA W/NEOMYCIN & 5% SHEEP BLOOD - # P3104 & Z3050 (November 6, 1987)

Other clearances for product code JSG

  • K882495 — THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007 (July 1, 1988)
  • K881532 — BLOOD AGAR BASE W/LOW PH (April 18, 1988)
  • K881543 — LETHEEN AGAR (April 18, 1988)
  • K881523 — DEXTROSE TRYPTONE BROTH (April 18, 1988)
  • K881541 — GELATIN (April 18, 1988)
  • K881554 — SKIM MILK DEHYDRATED (April 18, 1988)
  • K881562 — TRYPTOSE BLOOD AGAR BASE (April 18, 1988)
  • K881563 — TRYPTOSE PHOSPHATE BROTH (April 18, 1988)
  • K881522 — DEXTROSE AGAR (April 18, 1988)
  • K881528 — CASEIN PEPTONE, LOW VITAMIN (April 18, 1988)