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FDA 510(k)

IPA FOR DETECTION OF PHENOBARBITAL

K-Number: K821543 · 1982-06-03

ApplicantElectro-Nucleonics Laboratories, Inc.
Decision Date1982-06-03
Product CodeLFN
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

IPA FOR DETECTION OF PHENOBARBITAL is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Nucleonics Laboratories, Inc.. It received FDA 510(k) clearance on 1982-06-03 under 510(k) number K821543. The device is classified under product code LFN. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IPA FOR DETECTION OF PHENOBARBITAL?

IPA FOR DETECTION OF PHENOBARBITAL is a medical device that received FDA 510(k) clearance on 1982-06-03. The listed applicant is Electro-Nucleonics Laboratories, Inc.. The 510(k) number is K821543.

When did IPA FOR DETECTION OF PHENOBARBITAL receive FDA 510(k) clearance?

IPA FOR DETECTION OF PHENOBARBITAL received FDA 510(k) clearance on 1982-06-03, under 510(k) number K821543.

Who is the listed applicant for IPA FOR DETECTION OF PHENOBARBITAL?

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

What is the FDA product code for IPA FOR DETECTION OF PHENOBARBITAL?

The FDA product code for IPA FOR DETECTION OF PHENOBARBITAL is LFN.

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Other records listing Electro-Nucleonics Laboratories, Inc. as applicant

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Related Devices (Code: LFN)

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.

K934388QMS PHENOBARBITALSeradyn, Inc.K864612DART PHENOBARBITAL ASSAY SYSTEMCoulter Electronics, Inc.K860304DUPONT PHENOBARBITAL ASSAYE.I. Dupont DE Nemours & Co., Inc.K860303DUPONT PHENOBARBITAL CALIBRATORE.I. Dupont DE Nemours & Co., 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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