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FDA 510(k)

SYNCHRON CX SYSTEMS (LAP) REAGENT KIT

K-Number: K895850 · 1989-12-05

ApplicantBeckman Instruments, Inc.
Decision Date1989-12-05
Product CodeJGG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYNCHRON CX SYSTEMS (LAP) 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 1989-12-05 under 510(k) number K895850. The device is classified under product code JGG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNCHRON CX SYSTEMS (LAP) REAGENT KIT?

SYNCHRON CX SYSTEMS (LAP) REAGENT KIT is a medical device that received FDA 510(k) clearance on 1989-12-05. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K895850.

When did SYNCHRON CX SYSTEMS (LAP) REAGENT KIT receive FDA 510(k) clearance?

SYNCHRON CX SYSTEMS (LAP) REAGENT KIT received FDA 510(k) clearance on 1989-12-05, under 510(k) number K895850.

Who is the listed applicant for SYNCHRON CX SYSTEMS (LAP) 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 SYNCHRON CX SYSTEMS (LAP) REAGENT KIT?

The FDA product code for SYNCHRON CX SYSTEMS (LAP) REAGENT KIT is JGG.

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Other records listing Beckman Instruments, Inc. as applicant

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Related Devices (Code: JGG)

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.

K844965LEUCINE AMINOPEPTIDASE REAGENTAlladin Diagnostic, 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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