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FDA 510(k)

CALIBRATOR, BOVINE SERUM

K-Number: K781702 · 1978-11-15

ApplicantBio-Reagents & Diagnostics, Inc.
Decision Date1978-11-15
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CALIBRATOR, BOVINE SERUM is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Reagents & Diagnostics, Inc.. It received FDA 510(k) clearance on 1978-11-15 under 510(k) number K781702. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CALIBRATOR, BOVINE SERUM?

CALIBRATOR, BOVINE SERUM is a medical device that received FDA 510(k) clearance on 1978-11-15. The listed applicant is Bio-Reagents & Diagnostics, Inc.. The 510(k) number is K781702.

When did CALIBRATOR, BOVINE SERUM receive FDA 510(k) clearance?

CALIBRATOR, BOVINE SERUM received FDA 510(k) clearance on 1978-11-15, under 510(k) number K781702.

Who is the listed applicant for CALIBRATOR, BOVINE SERUM?

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

What is the FDA product code for CALIBRATOR, BOVINE SERUM?

The FDA product code for CALIBRATOR, BOVINE SERUM is JIX.

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Other records listing Bio-Reagents & 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.

K771894LDH ISOENZYME CONTROLK770555CPK ISOENZYME CONTROLK760730ANTICONVULSANT CONTROL SERUM

Related Devices (Code: JIX)

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.

K161140VITROS Chemistry Products Calibrator Kit 3Ortho-Clinical Diagnostics, Inc.K133330C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEINRoche DiagnosticsK130765ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL IIElitechgroupK123321DIMENSION CHEMISTRY III CALIBRATORYSiemens Healthcare DiagnosticsK123372ABBOTT LIPID MULTI CONSTITUENT CALIBRATORAbbott LaboratoriesK122398RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORSSiemens Healthcare Diagnostics, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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