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FDA 510(k)

H-D-EL

K-Number: K790372 · 1979-05-03

ApplicantGeneral Diagnostics
Decision Date1979-05-03
Product CodeLBR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

H-D-EL is the device name listed in this FDA 510(k) record. The listed applicant is General Diagnostics. It received FDA 510(k) clearance on 1979-05-03 under 510(k) number K790372. The device is classified under product code LBR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the H-D-EL?

H-D-EL is a medical device that received FDA 510(k) clearance on 1979-05-03. The listed applicant is General Diagnostics. The 510(k) number is K790372.

When did H-D-EL receive FDA 510(k) clearance?

H-D-EL received FDA 510(k) clearance on 1979-05-03, under 510(k) number K790372.

Who is the listed applicant for H-D-EL?

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

What is the FDA product code for H-D-EL?

The FDA product code for H-D-EL is LBR.

Other records listing General Diagnostics 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.

K882663BARBITURATE ENZYME IMMUNOASSAY KITK872882CANNABINOID ENZYME IMMUNOASSAY KITK871305COCAINE METABOLITE ENZYME IMMUNOASSAY KITK864993QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINEK863877BENZODIAZEPINE ENZYME IMMUNOASSAY KITK842307GENERAL DIAG. CEFONICID 30MCG ANTIMIC

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Related Devices (Code: LBR)

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.

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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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