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FDA 510(k)

NINHYDRIN REAGENT KIT

K-Number: K780847 · 1978-06-13

ApplicantBeckman Instruments, Inc.
Decision Date1978-06-13
Product CodeJMX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NINHYDRIN REAGENT 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 1978-06-13 under 510(k) number K780847. The device is classified under product code JMX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NINHYDRIN REAGENT KIT?

NINHYDRIN REAGENT KIT is a medical device that received FDA 510(k) clearance on 1978-06-13. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K780847.

When did NINHYDRIN REAGENT KIT receive FDA 510(k) clearance?

NINHYDRIN REAGENT KIT received FDA 510(k) clearance on 1978-06-13, under 510(k) number K780847.

Who is the listed applicant for NINHYDRIN REAGENT 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 NINHYDRIN REAGENT KIT?

The FDA product code for NINHYDRIN REAGENT KIT is JMX.

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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: JMX)

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.

K863188HPL RIA KITBiotecx Laboratories, 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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