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FDA 510(k)

S/P SURE-CAP

K-Number: K812921 · 1981-11-06

ApplicantAmerican Dade
Decision Date1981-11-06
Product CodeGIO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

S/P SURE-CAP is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1981-11-06 under 510(k) number K812921. The device is classified under product code GIO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S/P SURE-CAP?

S/P SURE-CAP is a medical device that received FDA 510(k) clearance on 1981-11-06. The listed applicant is American Dade. The 510(k) number is K812921.

When did S/P SURE-CAP receive FDA 510(k) clearance?

S/P SURE-CAP received FDA 510(k) clearance on 1981-11-06, under 510(k) number K812921.

Who is the listed applicant for S/P SURE-CAP?

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

What is the FDA product code for S/P SURE-CAP?

The FDA product code for S/P SURE-CAP is GIO.

Other records listing American Dade 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.

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Related Devices (Code: GIO)

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.

K972969QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEMInnovative Medical Technologies, Inc.K941291MONOJECT SAMPLETTE SEPARATOR TUBESherwood Medical Co.K894851TRU-TRAXHumagen, Inc.K885324HEMA(PRO)TEC(TION)Medical Products Search, Inc.K885138CAPILLARY TUBE, BLOOD COLLECTIONCoeur Laboratories, Inc.K884623SAFE-TEC CAPILLARY BLOOD COLLECTION TUBESafe-Tec Clinical Products, 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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