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510(k) K851996

LD-L REAGENT by Alpkem Corp. — Product Code CFJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 1985
Date Received
May 7, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
Device Class
Class II
Regulation Number
862.1440
Review Panel
CH
Submission Type

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  • K890337 — TRIGLYCERIDES - GPO REAGENT (March 9, 1989)
  • K890336 — GLUCOSE (GOD) REAGENT (February 27, 1989)
  • K890335 — SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU. (February 17, 1989)
  • K890332 — RFA/2 RAPID FLOW ANALYZER W/COMPUTER (February 17, 1989)
  • K890333 — ALBUMIN REAGENT (February 17, 1989)
  • K883020 — RFA-300 RAPID FLOW ANALYZER W/COMPUTER (September 2, 1988)
  • K860367 — MAGNESIUM (SUBSTRATE, ENZYME, REAGENT) (April 11, 1986)

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