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510(k) K834294

ELTRACHEM DIATRAC GLYCOSYLATED HEMOGLOB by Emd Chemicals, Inc. — Product Code LCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1984
Date Received
December 8, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Glycosylated Hemoglobin
Device Class
Class II
Regulation Number
864.7470
Review Panel
HE
Submission Type

Other clearances by Emd Chemicals, Inc.

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  • K990516 — ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS (March 31, 1999)
  • K981926 — ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS (July 22, 1998)
  • K973054 — ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS (October 1, 1997)
  • K951494 — AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR) (December 11, 1995)
  • K951750 — GLUCOSE TEST ITEM NUMBER 97375/94 (September 6, 1995)
  • K950234 — TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2 (June 14, 1995)
  • K950128 — TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2 (May 15, 1995)
  • K945322 — PHOSPHORUS TEST (PHOS) ITEM NUMBER 65416 (December 7, 1994)
  • K945368 — PHOSPHORUS TEST (PHOS) (December 2, 1994)

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