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510(k) K873704

MOTILITY INDOLE ORNATHINE (MIO) PRODUCT #T3053 by Lakewood Biochemical Co., Inc. — Product Code JSH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 1987
Date Received
September 14, 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

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  • K882463 — POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421 (June 22, 1988)
  • K882182 — SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326 (June 6, 1988)
  • K880947 — NUTRIENT AGAR PLATE, SLANT TUBE AND BROTH TUBE (April 1, 1988)
  • K880946 — NUTRIENT GELATIN - PRODUCT NUMBER T2860 (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 JSH

  • K881553 — RUSSELL DOUBLE SUGAR AGAR (April 18, 1988)
  • K881486 — DNASE TEST AGAR (April 18, 1988)
  • K881551 — PHENOL RED BROTH BASE (April 18, 1988)
  • K881560 — UREA BROTH (April 18, 1988)
  • K881540 — FLO AGAR (April 18, 1988)
  • K881559 — UREA AGAR BASE (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)