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FDA 510(k)

ADDITIONAL REAGENTS KITS FOR IMM. SYSTEM

K-Number: K780913 · 1978-06-22

ApplicantBeckman Instruments, Inc.
Decision Date1978-06-22
Product CodeDCF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ADDITIONAL REAGENTS KITS FOR IMM. SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Instruments, Inc.. It received FDA 510(k) clearance on 1978-06-22 under 510(k) number K780913. The device is classified under product code DCF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADDITIONAL REAGENTS KITS FOR IMM. SYSTEM?

ADDITIONAL REAGENTS KITS FOR IMM. SYSTEM is a medical device that received FDA 510(k) clearance on 1978-06-22. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K780913.

When did ADDITIONAL REAGENTS KITS FOR IMM. SYSTEM receive FDA 510(k) clearance?

ADDITIONAL REAGENTS KITS FOR IMM. SYSTEM received FDA 510(k) clearance on 1978-06-22, under 510(k) number K780913.

Who is the listed applicant for ADDITIONAL REAGENTS KITS FOR IMM. SYSTEM?

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

What is the FDA product code for ADDITIONAL REAGENTS KITS FOR IMM. SYSTEM?

The FDA product code for ADDITIONAL REAGENTS KITS FOR IMM. SYSTEM is DCF.

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Other records listing Beckman Instruments, 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.

K973448ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469K982250ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERK981403IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENTK981354ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211K980173ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505K974816ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229

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Related Devices (Code: DCF)

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.

K153560Optilite Low Level Albumin KitThe Binding Site Group , Ltd.K121045HUMAN ALBUMIN CSF KITThe Binding Site Group , Ltd.K113072TINA-QUANT ALBUMIN GEN.2Roche Diagnostics OperationsK101089EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATORMedica Corp.K101203TINA-QUANT ALBUMIN GEN 2Roche DiagnosticsK100853COBAS 8000 MODULAR SERIES ANALYZERRoche Diagnostics 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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