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FDA 510(k)

HUMAN C-PEPTIDE OF INSULIN BY RADIOIMM.

K-Number: K820666 · 1982-07-13

ApplicantImmuno Nuclear Corp.
Decision Date1982-07-13
Product CodeJKD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HUMAN C-PEPTIDE OF INSULIN BY RADIOIMM. is the device name listed in this FDA 510(k) record. The listed applicant is Immuno Nuclear Corp.. It received FDA 510(k) clearance on 1982-07-13 under 510(k) number K820666. The device is classified under product code JKD. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HUMAN C-PEPTIDE OF INSULIN BY RADIOIMM.?

HUMAN C-PEPTIDE OF INSULIN BY RADIOIMM. is a medical device that received FDA 510(k) clearance on 1982-07-13. The listed applicant is Immuno Nuclear Corp.. The 510(k) number is K820666.

When did HUMAN C-PEPTIDE OF INSULIN BY RADIOIMM. receive FDA 510(k) clearance?

HUMAN C-PEPTIDE OF INSULIN BY RADIOIMM. received FDA 510(k) clearance on 1982-07-13, under 510(k) number K820666.

Who is the listed applicant for HUMAN C-PEPTIDE OF INSULIN BY RADIOIMM.?

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

What is the FDA product code for HUMAN C-PEPTIDE OF INSULIN BY RADIOIMM.?

The FDA product code for HUMAN C-PEPTIDE OF INSULIN BY RADIOIMM. is JKD.

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Other records listing Immuno Nuclear Corp. as applicant

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Related Devices (Code: JKD)

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.

K951848AIA-PACK CPR ASSAYTosoh Medics, Inc.K943767IMMULITE C-PEPTIDEDiagnostic Products Corp.K896420DSL C-PEPTIDE RIA (DSL #7000)Diagnostic Systems Laboratories, Inc.K854066DOUBLE ANTIBODY C-PEPTIDE RIA KITDiagnostic Products Corp.K842267C-PEP-RIA-100Institut National Des RadioelementsK833396C-PEPTIDE RADIOIMMUNOASSAY TEST KITSerono 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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