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510(k) K821983

TITAN GEL LDH ISOENZYME KIT by Helena Laboratories — Product Code CEX

K821983 is an FDA 510(k) premarket notification submitted by Helena Laboratories for the device "TITAN GEL LDH ISOENZYME KIT". The FDA issued a decision of Substantially Equivalent on December 22, 1982. The device falls under product code CEX (Chromatographic Separation, Lactate Dehydrogenase Isoenzymes), a Class II device regulated under 21 CFR 862.1445. Helena Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1982
Date Received
July 6, 1982
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 Helena Laboratories

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  • K192931 — V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control (April 19, 2022)
  • K131479 — V8 SP NORMAL CONTROL, ABNORMAL CONTROL (October 7, 2013)
  • K100103 — SPECIALTY ASSAYED CONTROL-2 (December 15, 2010)
  • K061991 — PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA (February 23, 2007)
  • K061069 — SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, S (July 6, 2006)
  • K061014 — ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP (May 10, 2006)
  • K050053 — HEMORAM/AGGRAM ANALYZER (July 11, 2005)
  • K024162 — SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 (February 19, 2003)
  • K023761 — PLATELETWORKS, MODELS PW-A, PW-C (February 14, 2003)

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)
  • K821879 — ULTRACHEM T.P. (July 14, 1982)
  • K800129 — CENTRIFICHEM CREATININE (February 13, 1980)
  • K772356 — LDH ISOENZYME COLUMN REAGENT SET (January 24, 1978)
  • K771894 — LDH ISOENZYME CONTROL (December 22, 1977)

FDA data resources