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510(k) K821038

FAST VIOLET B by Dms Laboratories — Product Code JTS

K821038 is an FDA 510(k) premarket notification submitted by Dms Laboratories for the device "FAST VIOLET B". The FDA issued a decision of Substantially Equivalent on May 27, 1982. The device falls under product code JTS (Stains, Microbiologic), a Class I device regulated under 21 CFR 864.1850. Dms Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1982
Date Received
April 13, 1982
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 Dms Laboratories

  • K831186 — RAPID NFT (May 9, 1983)
  • K831187 — TRP (May 9, 1983)
  • K830437 — CHS (March 17, 1983)
  • K823102 — AGAR P (December 3, 1982)
  • K813613 — RAPID CH (February 22, 1982)
  • K813612 — RAPID ZYME (February 22, 1982)
  • K820211 — NINHYDRIN (February 12, 1982)
  • K820213 — SALINE SOLUTION (February 12, 1982)
  • K820209 — ZYME B (February 12, 1982)
  • K820210 — IND (February 12, 1982)

Other clearances for product code JTS

  • K960090 — CALCOFLUOR WHITE STAIN KIT (March 19, 1996)
  • K960095 — BACTIDROP CALCOFLUOR WHITE (March 19, 1996)
  • K920976 — BACTIDROP INDIA INK (June 9, 1992)
  • K920975 — BACTIDROP CALCOFLUOR WHITE (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