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510(k) K860367

MAGNESIUM (SUBSTRATE, ENZYME, REAGENT) by Alpkem Corp. — Product Code JGF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 1986
Date Received
February 3, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes
Device Class
Class II
Regulation Number
862.1445
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)
  • K851990 — INTERNAL STANDARD SOLUTION, EXTERNAL STANDARD SOLU (June 25, 1985)

Other clearances for product code JGF

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  • K925188 — ABBOTT QUICKSTART LD-1, MODIFICATION (February 5, 1993)
  • K914261 — ABBOTT QUICKSTART LD-1,#5A30 (October 21, 1991)
  • K890996 — LD1 ISOENZYME REAGENT KIT (May 5, 1989)
  • K871240 — ABBOTT A-GENT LD-1 ISOZYME REAGENT (May 13, 1987)