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510(k) K880946

NUTRIENT GELATIN - PRODUCT NUMBER T2860 by Lakewood Biochemical Co., Inc. — Product Code JSF

K880946 is an FDA 510(k) premarket notification submitted by Lakewood Biochemical Co., Inc. for the device "NUTRIENT GELATIN - PRODUCT NUMBER T2860". The FDA issued a decision of Substantially Equivalent on April 1, 1988. The device falls under product code JSF (Culture Media, Single Biochemical Test), a Class I device regulated under 21 CFR 866.2320. Lakewood Biochemical Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1988
Date Received
March 7, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Single Biochemical Test
Device Class
Class I
Regulation Number
866.2320
Review Panel
MI
Submission Type

Other clearances by Lakewood Biochemical Co., Inc.

  • K882495 — THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007 (July 1, 1988)
  • K882351 — MUELLER HINTON AGAR PLATES P3318/1&2/P3418/P34181 (June 28, 1988)
  • 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)
  • 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)
  • K874344 — QUAD PLATE (4 DIFFERENT MEDIA) (November 6, 1987)

Other clearances for product code JSF

  • K880126 — LAURYL TRYPTOSE BROTH (March 31, 1988)
  • K880120 — MOELLERS DECARBOXYLASE, LYSINE (March 31, 1988)
  • K880119 — MOELLERS DECARBOXYLASE, ONITHINE (March 31, 1988)
  • K880106 — ACETAMIDE AGAR SLANT (March 30, 1988)
  • K880110 — CYSTINE TRYPTIC MEDIUM W/DEXTROSE (March 30, 1988)
  • K880112 — CYSTINE TRYPTIC MEDIUM W/ MALTOSE (March 30, 1988)
  • K880113 — CYSTINE TRYPTIC MEDIUM W/LACTOSE (March 30, 1988)
  • K880139 — ONPG TEST REAGENT (March 30, 1988)
  • K880129 — BRILLIANT GREEN BILE BROTH (March 30, 1988)
  • K880135 — NITRATE BROTH (March 30, 1988)

FDA data resources