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FDA 510(k)

C-PEPTIDE RADIOIMMUNOASSAY TEST KIT

K-Number: K833396 · 1984-04-13

ApplicantSerono Diagnostics, Inc.
Decision Date1984-04-13
Product CodeJKD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

C-PEPTIDE RADIOIMMUNOASSAY TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Serono Diagnostics, Inc.. It received FDA 510(k) clearance on 1984-04-13 under 510(k) number K833396. 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 C-PEPTIDE RADIOIMMUNOASSAY TEST KIT?

C-PEPTIDE RADIOIMMUNOASSAY TEST KIT is a medical device that received FDA 510(k) clearance on 1984-04-13. The listed applicant is Serono Diagnostics, Inc.. The 510(k) number is K833396.

When did C-PEPTIDE RADIOIMMUNOASSAY TEST KIT receive FDA 510(k) clearance?

C-PEPTIDE RADIOIMMUNOASSAY TEST KIT received FDA 510(k) clearance on 1984-04-13, under 510(k) number K833396.

Who is the listed applicant for C-PEPTIDE RADIOIMMUNOASSAY TEST KIT?

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

What is the FDA product code for C-PEPTIDE RADIOIMMUNOASSAY TEST KIT?

The FDA product code for C-PEPTIDE RADIOIMMUNOASSAY TEST KIT is JKD.

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Other records listing Serono Diagnostics, 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.

K953598SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERSK942051SR1 DHEA-S ENZYME IMMUNOASSAYK883085T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHASK882340LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHAK880388T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASEK874866T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE

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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 RadioelementsK820666HUMAN C-PEPTIDE OF INSULIN BY RADIOIMM.Immuno Nuclear Corp.

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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