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510(k) K821879

ULTRACHEM T.P. by Harleco Diagnostics — Product Code CEX

K821879 is an FDA 510(k) premarket notification submitted by Harleco Diagnostics for the device "ULTRACHEM T.P.". The FDA issued a decision of Substantially Equivalent on July 14, 1982. The device falls under product code CEX (Chromatographic Separation, Lactate Dehydrogenase Isoenzymes), a Class II device regulated under 21 CFR 862.1445. Harleco Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1982
Date Received
June 25, 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 Harleco Diagnostics

  • K823147 — URIC ACID STANDARD, 8MG/DL #65078 (November 22, 1982)
  • K822852 — TRIGLYCERIDE CALIBRATOR (October 27, 1982)
  • K822323 — ULTRACHEM BUN-UV, 65080 & 65081 (September 2, 1982)
  • K821880 — ULTRA CHEM ALB (July 14, 1982)
  • K821878 — ULTRAZYME PLUS LDH (July 14, 1982)
  • K821883 — ULTRAZYME PLUS CK-I (July 14, 1982)
  • K821877 — ULTRAZYME PLUS HBD (July 14, 1982)
  • K821882 — ULTRAZYME PLUS GPT (July 14, 1982)
  • K821871 — ULTRAZYME PLUS 2GT (July 14, 1982)
  • K821872 — ULTRACHEM URIC ACID AIDH (July 14, 1982)

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)
  • 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