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FDA 510(k)

S-UREA-N, IN VITRO DIAG FOR BUN

K-Number: K761152 · 1976-12-09

ApplicantAdvanced Biomedical Methods, Inc.
Decision Date1976-12-09
Product CodeCDL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

S-UREA-N, IN VITRO DIAG FOR BUN is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Biomedical Methods, Inc.. It received FDA 510(k) clearance on 1976-12-09 under 510(k) number K761152. The device is classified under product code CDL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S-UREA-N, IN VITRO DIAG FOR BUN?

S-UREA-N, IN VITRO DIAG FOR BUN is a medical device that received FDA 510(k) clearance on 1976-12-09. The listed applicant is Advanced Biomedical Methods, Inc.. The 510(k) number is K761152.

When did S-UREA-N, IN VITRO DIAG FOR BUN receive FDA 510(k) clearance?

S-UREA-N, IN VITRO DIAG FOR BUN received FDA 510(k) clearance on 1976-12-09, under 510(k) number K761152.

Who is the listed applicant for S-UREA-N, IN VITRO DIAG FOR BUN?

The FDA 510(k) record lists Advanced Biomedical Methods, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for S-UREA-N, IN VITRO DIAG FOR BUN?

The FDA product code for S-UREA-N, IN VITRO DIAG FOR BUN is CDL.

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Other records listing Advanced Biomedical Methods, Inc. as applicant

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Related Devices (Code: CDL)

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.

K896845RAICHEM(TM) UREA NITROGEN (COLOR) REAGENTReagents Applications, Inc.K893128STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010Stanbio LaboratoryK871651COLORIMETRIC BUN REAGENT KITBiochemical Trade, Inc.K864742UREA NITROGEN(BUN), COLORIMETRIC METHODTech-Co, Inc.K863889UREA NITROGEN TESTU. S. Diagnostics, Inc.K863076UREAFASTJ. D. Assoc.

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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