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510(k) K864731

OCEAN SCIENTIFIC VDRL TEST by Ocean Scientific, Inc. — Product Code GMQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1987
Date Received
December 4, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Nontreponemal, All
Device Class
Class II
Regulation Number
866.3820
Review Panel
MI
Submission Type

Other clearances by Ocean Scientific, Inc.

  • K893810 — IMMUNO-WASH AUTOMATED TUBE WASHER (August 3, 1989)
  • K873638 — MICRO-CHEM ANALYZER (September 29, 1987)
  • K863976 — OCEAN SCIENTIFIC VACUTEST (October 24, 1986)
  • K860987 — MINI-CHEM ANALYZER (May 5, 1986)
  • K840340 — CHEM-STAT ANALYZER (March 23, 1984)

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