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FDA 510(k)

SELF ASSURE/GHB (CAPILLARY-BLOOD COLLECTION KIT)

K-Number: K861697 · 1986-08-19

ApplicantAwareness Technology, Inc.
Decision Date1986-08-19
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SELF ASSURE/GHB (CAPILLARY-BLOOD COLLECTION KIT) is the device name listed in this FDA 510(k) record. The listed applicant is Awareness Technology, Inc.. It received FDA 510(k) clearance on 1986-08-19 under 510(k) number K861697. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SELF ASSURE/GHB (CAPILLARY-BLOOD COLLECTION KIT)?

SELF ASSURE/GHB (CAPILLARY-BLOOD COLLECTION KIT) is a medical device that received FDA 510(k) clearance on 1986-08-19. The listed applicant is Awareness Technology, Inc.. The 510(k) number is K861697.

When did SELF ASSURE/GHB (CAPILLARY-BLOOD COLLECTION KIT) receive FDA 510(k) clearance?

SELF ASSURE/GHB (CAPILLARY-BLOOD COLLECTION KIT) received FDA 510(k) clearance on 1986-08-19, under 510(k) number K861697.

Who is the listed applicant for SELF ASSURE/GHB (CAPILLARY-BLOOD COLLECTION KIT)?

The FDA 510(k) record lists Awareness Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SELF ASSURE/GHB (CAPILLARY-BLOOD COLLECTION KIT)?

The FDA product code for SELF ASSURE/GHB (CAPILLARY-BLOOD COLLECTION KIT) is LCP.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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