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510(k) K820208

ZYME A by Dms Laboratories

K820208 is an FDA 510(k) premarket notification submitted by Dms Laboratories for the device "ZYME A". The FDA issued a decision of Substantially Equivalent on February 5, 1982. 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

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)
  • K820212 — OXI (February 12, 1982)
  • K820213 — SALINE SOLUTION (February 12, 1982)
  • K820211 — NINHYDRIN (February 12, 1982)

FDA data resources