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510(k) K874345

TSA W/NEOMYCIN & 5% SHEEP BLOOD - # P3104 & Z3050 by Lakewood Biochemical Co., Inc. — Product Code JSJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1987
Date Received
October 20, 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

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  • 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)
  • K875136 — COLUMBIA BLOOD AGAR P3308/ COLUMBIA CNA P3750 (January 12, 1988)
  • K874538 — TODD-HEWITT BROTH (0.5ML)#3099 & (5.OML)#T3516 (November 20, 1987)
  • K874537 — KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGAR (November 20, 1987)

Other clearances for product code JSJ

  • K882463 — POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421 (June 22, 1988)
  • K881544 — LITTMAN AGAR (April 18, 1988)
  • K881574 — W-L DIFFERENTIAL MEDIUM (April 18, 1988)
  • K881570 — SABOURAUD MALTOSE AGAR (April 18, 1988)
  • K881565 — INHIBITORY MOLD AGAR (April 18, 1988)
  • K881561 — TERGITOL 7 BROTH (April 18, 1988)
  • K881549 — MYCOLOGICAL AGAR W/LOW PH (April 18, 1988)
  • K881524 — DERMATOPHYTE TEST MEDIUM (April 18, 1988)
  • K881547 — MITIS SALIVARIUS AGAR (April 18, 1988)
  • K881571 — YM BROTH (April 18, 1988)