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510(k) K861697

SELF ASSURE/GHB (CAPILLARY-BLOOD COLLECTION KIT) by Awareness Technology, Inc. — Product Code LCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1986
Date Received
May 5, 1986
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

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  • 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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