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FDA 510(k)

PORPHOBILINOGEN (PBG)

K-Number: K961984 · 1996-12-10

ApplicantTrace America, Inc.
Decision Date1996-12-10
Product CodeJNF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PORPHOBILINOGEN (PBG) is the device name listed in this FDA 510(k) record. The listed applicant is Trace America, Inc.. It received FDA 510(k) clearance on 1996-12-10 under 510(k) number K961984. The device is classified under product code JNF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORPHOBILINOGEN (PBG)?

PORPHOBILINOGEN (PBG) is a medical device that received FDA 510(k) clearance on 1996-12-10. The listed applicant is Trace America, Inc.. The 510(k) number is K961984.

When did PORPHOBILINOGEN (PBG) receive FDA 510(k) clearance?

PORPHOBILINOGEN (PBG) received FDA 510(k) clearance on 1996-12-10, under 510(k) number K961984.

Who is the listed applicant for PORPHOBILINOGEN (PBG)?

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

What is the FDA product code for PORPHOBILINOGEN (PBG)?

The FDA product code for PORPHOBILINOGEN (PBG) is JNF.

Related Clinical Trials

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Other records listing Trace America, 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.

K003583LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901K980026GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)K980028ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)K980030AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)K973869TRACE REAGENT LINE FOR THE COBAS MIRAK974620AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)

View all 22 devices →

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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