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510(k) K781654

NEPHELRATE ANTIPERUMS LGM by Antibodies, Inc. — Product Code CFN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1978
Date Received
September 27, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Method, Nephelometric, Immunoglobulins (G, A, M)
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

Other clearances by Antibodies, Inc.

  • K890774 — GIARDEIA(TM) (April 4, 1989)
  • K843590 — DETECT-A-STREP (October 30, 1984)
  • K822892 — CORTISOL RIA KIT (November 1, 1982)
  • K812749 — ULTRA-DIG (October 19, 1981)
  • K812314 — CRITHIDNA ANTI-DNA TEST KIT (September 1, 1981)
  • K802877 — AMIKACIN RIA KIT (December 19, 1980)
  • K800743 — TOBRAMYCIN RIA KIT (April 16, 1980)
  • K791217 — TSH RIA KIT (September 4, 1979)
  • K781653 — NEPHELRATE ANTISERUMS C3C (November 8, 1978)
  • K781655 — NEPHELRATE ANTISERUMS 1GA (November 8, 1978)

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  • K162208 — DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent (January 9, 2017)
  • K150526 — Optilite IgG4 Kit (May 30, 2015)