FDA 510(k)

BLOOD GADS, ELECTROLYTE, GLUCOSE, LATATE AND BUN QUALITY CONTROL PRODUCT

K-Number: K943754 · 1994-09-14

Decision Date1994-09-14

Product CodeJJY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

BLOOD GADS, ELECTROLYTE, GLUCOSE, LATATE AND BUN QUALITY CONTROL PRODUCT is the device name listed in this FDA 510(k) record. The listed applicant is Bionostics, Inc.. It received FDA 510(k) clearance on 1994-09-14 under 510(k) number K943754. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLOOD GADS, ELECTROLYTE, GLUCOSE, LATATE AND BUN QUALITY CONTROL PRODUCT?

BLOOD GADS, ELECTROLYTE, GLUCOSE, LATATE AND BUN QUALITY CONTROL PRODUCT is a medical device that received FDA 510(k) clearance on 1994-09-14. The listed applicant is Bionostics, Inc.. The 510(k) number is K943754.

When did BLOOD GADS, ELECTROLYTE, GLUCOSE, LATATE AND BUN QUALITY CONTROL PRODUCT receive FDA 510(k) clearance?

BLOOD GADS, ELECTROLYTE, GLUCOSE, LATATE AND BUN QUALITY CONTROL PRODUCT received FDA 510(k) clearance on 1994-09-14, under 510(k) number K943754.

Who is the listed applicant for BLOOD GADS, ELECTROLYTE, GLUCOSE, LATATE AND BUN QUALITY CONTROL PRODUCT?

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

What is the FDA product code for BLOOD GADS, ELECTROLYTE, GLUCOSE, LATATE AND BUN QUALITY CONTROL PRODUCT?

The FDA product code for BLOOD GADS, ELECTROLYTE, GLUCOSE, LATATE AND BUN QUALITY CONTROL PRODUCT is JJY.

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Other records listing Bionostics, Inc. as applicant

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Related Devices (Code: JJY)

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Official Source

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