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510(k) K890281

HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES by Cambridge Bioscience Corp. — Product Code LSR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1989
Date Received
January 17, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagent, Borrelia Serological Reagent
Device Class
Class II
Regulation Number
866.3830
Review Panel
MI
Submission Type

Other clearances by Cambridge Bioscience Corp.

  • K881894 — ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48) (July 8, 1988)
  • K873312 — ADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TEST (February 24, 1988)
  • K873082 — ADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TEST (February 24, 1988)
  • K852969 — ROTACLONE ROTAVIRUS DIAGNOSTIC KIT (November 5, 1985)

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