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510(k) K852005

MG REAGENT by Alpkem Corp. — Product Code JGJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1985
Date Received
May 7, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Photometric Method, Magnesium
Device Class
Class I
Regulation Number
862.1495
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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  • K063208 — MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7 (January 19, 2007)
  • K040508 — VITALAB MAGNESIUM REAGENT (March 8, 2004)