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510(k) K871679

FOCUS-GHB by Awareness Technology, Inc. — Product Code LCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1987
Date Received
April 29, 1987
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 Awareness Technology, Inc.

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  • K010877 — CHEMWELL, MODEL 2900 (May 23, 2001)
  • K974762 — STAT TRACKS (January 28, 1998)
  • K943729 — DYE CHECK STRIPS 545-630 (December 29, 1994)
  • K941394 — STAT FAX 2600 (June 3, 1994)
  • K923598 — REDI-CHECK PHOTMETER Q.A. (October 14, 1992)
  • K900224 — STAT FAX(TM)-2100 (March 1, 1990)
  • K892656 — DRI-DYE CHECK STRIPS (TM)-405 (May 22, 1989)
  • K882938 — STAT FAX(TM) (September 9, 1988)

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