FDA 510(k)

MICROPROTEIN REAGENT SET

K-Number: K070757 · 2007-12-04

Decision Date2007-12-04

Product CodeJGP

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

MICROPROTEIN REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Pointe Scientific, Inc.,. It received FDA 510(k) clearance on 2007-12-04 under 510(k) number K070757. The device is classified under product code JGP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROPROTEIN REAGENT SET?

MICROPROTEIN REAGENT SET is a medical device that received FDA 510(k) clearance on 2007-12-04. The listed applicant is Pointe Scientific, Inc.,. The 510(k) number is K070757.

When did MICROPROTEIN REAGENT SET receive FDA 510(k) clearance?

MICROPROTEIN REAGENT SET received FDA 510(k) clearance on 2007-12-04, under 510(k) number K070757.

Who is the listed applicant for MICROPROTEIN REAGENT SET?

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

What is the FDA product code for MICROPROTEIN REAGENT SET?

The FDA product code for MICROPROTEIN REAGENT SET is JGP.

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Other records listing Pointe Scientific, Inc., as applicant

K062118POINTE 360 K070251CARBON DIOXIDE LIQUID STABLE REAGENT K070207MULTI-ANALYTE CHEMISTRY CALIBRATOR K070504AMMONIA/ALCOHOL CONTROL SET K061377APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS K051646ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH

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Related Devices (Code: JGP)

K964960VITROS CHEMISTRY PRODUCTS UPRO SLIDESJohnson & Johnson Clinical Diagnostics, Inc.K863112PROTEINMETERJ. D. Assoc.K821534HEMATOLOGY DATA MANAGEMENT SYSBiovation, Inc.K792347MICRO LOWRY PROTEINTESTPanmed, Inc.

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.