FDA 510(k)

SAC-CEL

K-Number: K813508 · 1981-12-29

Decision Date1981-12-29

Product CodeKTS

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

SAC-CEL is the device name listed in this FDA 510(k) record. The listed applicant is Burroughs Wellcome Co.. It received FDA 510(k) clearance on 1981-12-29 under 510(k) number K813508. The device is classified under product code KTS. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAC-CEL?

SAC-CEL is a medical device that received FDA 510(k) clearance on 1981-12-29. The listed applicant is Burroughs Wellcome Co.. The 510(k) number is K813508.

When did SAC-CEL receive FDA 510(k) clearance?

SAC-CEL received FDA 510(k) clearance on 1981-12-29, under 510(k) number K813508.

Who is the listed applicant for SAC-CEL?

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

What is the FDA product code for SAC-CEL?

The FDA product code for SAC-CEL is KTS.

Other records listing Burroughs Wellcome Co. 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.

K820069WELLCOGEN GROUP B K810215DAC-CEL HCG K810214DAC-CEL DIAGNATAL K810213DAC-CEL TSH K810212DAC-CEL T3 UPTAKE K791231DAC-CEL T4

View all 17 devices →

Related Devices (Code: KTS)

K792636CENTRIA RADIOIMMUNOASSAY SEPARATIONUnion Carbide Corp.K792637CENTRIA-SET TYPE D(ANTI-SHEEP/GOAT)Union Carbide Corp.K781070SECOND ANTIBODYPcl-Ria, 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.