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510(k) K873321

SABOUR DEXTROSE/BHI SD/BHI AGAR SLT TUBE #T4300 by Lakewood Biochemical Co., Inc. — Product Code KZI

K873321 is an FDA 510(k) premarket notification submitted by Lakewood Biochemical Co., Inc. for the device "SABOUR DEXTROSE/BHI SD/BHI AGAR SLT TUBE #T4300". The FDA issued a decision of Substantially Equivalent on September 29, 1987. The device falls under product code KZI (Culture Media, Enriched), a Class I device regulated under 21 CFR 866.2330. Lakewood Biochemical Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1987
Date Received
August 18, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Enriched
Device Class
Class I
Regulation Number
866.2330
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)
  • 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 KZI

  • K884208 — LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION) (October 25, 1988)
  • K881995 — DIAMOND'S MEDIUM MODIFIED (June 2, 1988)
  • K880131 — LOWENSTEIN-JENSEN, GRUFT (March 31, 1988)
  • K880134 — MIDDLEBROOK 7H11 AGAR (March 31, 1988)
  • K880122 — MIDDLEBROOK 7H9 BROTH (March 31, 1988)
  • K880138 — WALLENSTEIN MEDIUM SLANT (March 30, 1988)
  • K880109 — CYSTINE TRYPTIC MEDIUM BASE (March 30, 1988)
  • K880127 — POTATO DEXTROSE AGAR (March 7, 1988)
  • K874179 — BIOTIS (TM) SABHI (DOUBLE POUR) (January 28, 1988)
  • K874177 — BIOTIS (TM) BCYE (December 4, 1987)

FDA data resources