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FDA 510(k)

SECURE FDI TEST KIT

K-Number: K813216 · 1981-12-17

ApplicantBeckman Instruments, Inc.
Decision Date1981-12-17
Product CodeJHG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SECURE FDI TEST KIT 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 1981-12-17 under 510(k) number K813216. The device is classified under product code JHG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SECURE FDI TEST KIT?

SECURE FDI TEST KIT is a medical device that received FDA 510(k) clearance on 1981-12-17. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K813216.

When did SECURE FDI TEST KIT receive FDA 510(k) clearance?

SECURE FDI TEST KIT received FDA 510(k) clearance on 1981-12-17, under 510(k) number K813216.

Who is the listed applicant for SECURE FDI TEST KIT?

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 SECURE FDI TEST KIT?

The FDA product code for SECURE FDI TEST KIT is JHG.

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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: JHG)

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.

K061549AMNIOSTAT-FLM-PGIrvine Scientific Sales Co., Inc.K871593TDXR FETAL LUNG MATURITYAbbott LaboratoriesK834616AMNIO STAT-FLM AGGLUTINATION TESTHana Biologics, Inc.K822150AMNISTAT-FLMHana Biologics, Inc.K811588HELENA FETAL-TEK 200 METHODHelena LaboratoriesK790798FETAL MATURITY TEST PROCEDUREHelena Laboratories

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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