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510(k) K873413

GRAM CRYSTAL VIOLET/IODINE/ACETON ALCHL DECLR/SAFR by Lakewood Biochemical Co., Inc. — Product Code JTS

K873413 is an FDA 510(k) premarket notification submitted by Lakewood Biochemical Co., Inc. for the device "GRAM CRYSTAL VIOLET/IODINE/ACETON ALCHL DECLR/SAFR". The FDA issued a decision of Substantially Equivalent on October 6, 1987. The device falls under product code JTS (Stains, Microbiologic), a Class I device regulated under 21 CFR 864.1850. Lakewood Biochemical Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1987
Date Received
August 24, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stains, Microbiologic
Device Class
Class I
Regulation Number
864.1850
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)
  • 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 JTS

  • K960090 — CALCOFLUOR WHITE STAIN KIT (March 19, 1996)
  • K960095 — BACTIDROP CALCOFLUOR WHITE (March 19, 1996)
  • K920975 — BACTIDROP CALCOFLUOR WHITE (June 9, 1992)
  • K920976 — BACTIDROP INDIA INK (June 9, 1992)
  • K920970 — BACTIDROP KOH (10%) (June 9, 1992)
  • K893530 — IRISTAIN FORMULA 2, PARTS 1 AND 2 (June 13, 1989)
  • K890861 — ATS DOBELL & O'CONNOR'S IODINE (March 23, 1989)
  • K890020 — ATS LUGOL'S IODINE SOLUTION (February 24, 1989)
  • K884069 — SNAP N' STAIN IODINE STAIN (October 25, 1988)
  • K883052 — METHENO-STAIN KIT (August 30, 1988)

FDA data resources