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510(k) K820206

NIT 1 by Dms Laboratories — Product Code JTO

K820206 is an FDA 510(k) premarket notification submitted by Dms Laboratories for the device "NIT 1". The FDA issued a decision of Substantially Equivalent on February 5, 1982. The device falls under product code JTO (Discs, Strips And Reagents, Microorganism Differentiation), a Class I device regulated under 21 CFR 866.2660. Dms Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1982
Date Received
January 26, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Discs, Strips And Reagents, Microorganism Differentiation
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

Other clearances by Dms Laboratories

  • K831187 — TRP (May 9, 1983)
  • K831186 — RAPID NFT (May 9, 1983)
  • K830437 — CHS (March 17, 1983)
  • K823102 — AGAR P (December 3, 1982)
  • K821038 — FAST VIOLET B (May 27, 1982)
  • K813612 — RAPID ZYME (February 22, 1982)
  • K813613 — RAPID CH (February 22, 1982)
  • K820210 — IND (February 12, 1982)
  • K820211 — NINHYDRIN (February 12, 1982)
  • K820213 — SALINE SOLUTION (February 12, 1982)

Other clearances for product code JTO

  • K050352 — IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT (September 1, 2005)
  • K970832 — PYR SWAB (April 24, 1997)
  • K970834 — GRAM SWAB (April 17, 1997)
  • K970833 — INDOLE SWAB (April 2, 1997)
  • K970009 — LYFO(TM) DIFFERENTIAL DISK-BACITRACIN (February 6, 1997)
  • K962966 — IDS RAPID CB PLUS SYSTEM (October 8, 1996)
  • K961191 — COLISCREEN (June 17, 1996)
  • K960996 — M. CAT BUTYRATE DISK (April 18, 1996)
  • K955826 — GIBSON ID-M. CAT. (February 29, 1996)
  • K954783 — DRYSLIDE CARTARRHALIS (February 6, 1996)

FDA data resources