Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

URIC ACID/ALDH

K-Number: K802371 · 1980-10-23

ApplicantBoehringer Mannheim Corp.
Decision Date1980-10-23
Product CodeCDO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URIC ACID/ALDH is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1980-10-23 under 510(k) number K802371. The device is classified under product code CDO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URIC ACID/ALDH?

URIC ACID/ALDH is a medical device that received FDA 510(k) clearance on 1980-10-23. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K802371.

When did URIC ACID/ALDH receive FDA 510(k) clearance?

URIC ACID/ALDH received FDA 510(k) clearance on 1980-10-23, under 510(k) number K802371.

Who is the listed applicant for URIC ACID/ALDH?

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

What is the FDA product code for URIC ACID/ALDH?

The FDA product code for URIC ACID/ALDH is CDO.

Other records listing Boehringer Mannheim Corp. 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.

K984326ELECYS IGE ASSAYK983047ACCU-CHEK HQ SYSTEMK984419ELECSYS IGE CALCHECKK984425MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATORK984372ELECSYS CALCHECK TROPONIN TK984105ELECSYS TROPONIN T STAT TEST

View all 340 devices →

Related Devices (Code: CDO)

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.

K033278RANDOX URIC ACIDRandox Laboratories, Ltd.K992798SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100PSigma Diagnostics, Inc.K982251SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KITSigma Diagnostics, Inc.K981766URIC ACIDAbbott LaboratoriesK981189URIC ACIDAbbott LaboratoriesK971485URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)Trace America, 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.

↑