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510(k) K820209

ZYME B by Dms Laboratories — Product Code JTO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 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

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  • 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)
  • K820211 — NINHYDRIN (February 12, 1982)
  • K820210 — IND (February 12, 1982)
  • K820212 — OXI (February 12, 1982)

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