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510(k) K771894

LDH ISOENZYME CONTROL by Bio-Reagents & Diagnostics, Inc. — Product Code CEX

K771894 is an FDA 510(k) premarket notification submitted by Bio-Reagents & Diagnostics, Inc. for the device "LDH ISOENZYME CONTROL". The FDA issued a decision of Substantially Equivalent on December 22, 1977. The device falls under product code CEX (Chromatographic Separation, Lactate Dehydrogenase Isoenzymes), a Class II device regulated under 21 CFR 862.1445. Bio-Reagents & Diagnostics, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1977
Date Received
October 6, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chromatographic Separation, Lactate Dehydrogenase Isoenzymes
Device Class
Class II
Regulation Number
862.1445
Review Panel
CH
Submission Type

Other clearances by Bio-Reagents & Diagnostics, Inc.

  • K781702 — CALIBRATOR, BOVINE SERUM (November 15, 1978)
  • K770555 — CPK ISOENZYME CONTROL (June 3, 1977)
  • K760730 — ANTICONVULSANT CONTROL SERUM (October 7, 1976)

Other clearances for product code CEX

  • K872891 — LACTATE DEHYDROGENASE ISOENZYME 1 (September 16, 1987)
  • K851521 — LD-1(IMMUNO) SEPARATION SET (May 10, 1985)
  • K842018 — ISO-SEP SYSTEM (September 28, 1984)
  • K821983 — TITAN GEL LDH ISOENZYME KIT (December 22, 1982)
  • K821879 — ULTRACHEM T.P. (July 14, 1982)
  • K800129 — CENTRIFICHEM CREATININE (February 13, 1980)
  • K772356 — LDH ISOENZYME COLUMN REAGENT SET (January 24, 1978)

FDA data resources