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FDA 510(k)

BINAXNOW G6PD TEST

K-Number: K080003 · 2008-10-23

ApplicantBinax, Inc.
Decision Date2008-10-23
Product CodeJBF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BINAXNOW G6PD TEST is the device name listed in this FDA 510(k) record. The listed applicant is Binax, Inc.. It received FDA 510(k) clearance on 2008-10-23 under 510(k) number K080003. The device is classified under product code JBF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BINAXNOW G6PD TEST?

BINAXNOW G6PD TEST is a medical device that received FDA 510(k) clearance on 2008-10-23. The listed applicant is Binax, Inc.. The 510(k) number is K080003.

When did BINAXNOW G6PD TEST receive FDA 510(k) clearance?

BINAXNOW G6PD TEST received FDA 510(k) clearance on 2008-10-23, under 510(k) number K080003.

Who is the listed applicant for BINAXNOW G6PD TEST?

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

What is the FDA product code for BINAXNOW G6PD TEST?

The FDA product code for BINAXNOW G6PD TEST is JBF.

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Other records listing Binax, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K090301BINAXNOW PBP2A TEST, MODEL 890-000K091766CLEARVIEW EXACT PBP2A TEST, MODEL 891-000K090964BINAXNOX STAPHYLOCOCCUS AUREUS TESTK091489CLEARVIEW ADVANCED STREP A , MODEL 737-430K083744BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010K092223MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST

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Related Devices (Code: JBF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201049FINDER G6PDBaebies, Inc.K161364BinaxNOW G6PD TestAlere Scarborough, Inc.K024006G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASEPointe Scientific, Inc.,K933934GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-ASigma Diagnostics, 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.

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