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FDA 510(k)

TDX REA TRIGLYCERIDES

K-Number: K852556 · 1985-07-22

ApplicantAbbott Laboratories
Decision Date1985-07-22
Product CodeJGW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TDX REA TRIGLYCERIDES is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1985-07-22 under 510(k) number K852556. The device is classified under product code JGW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TDX REA TRIGLYCERIDES?

TDX REA TRIGLYCERIDES is a medical device that received FDA 510(k) clearance on 1985-07-22. The listed applicant is Abbott Laboratories. The 510(k) number is K852556.

When did TDX REA TRIGLYCERIDES receive FDA 510(k) clearance?

TDX REA TRIGLYCERIDES received FDA 510(k) clearance on 1985-07-22, under 510(k) number K852556.

Who is the listed applicant for TDX REA TRIGLYCERIDES?

The FDA 510(k) record lists Abbott Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TDX REA TRIGLYCERIDES?

The FDA product code for TDX REA TRIGLYCERIDES is JGW.

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Related Devices (Code: JGW)

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.

K872912TRIGLYCERIDE (UV) REAGENTSigma Chemical Co.K780439PRECIMAT GLYCEROLBoehringer Mannheim 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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