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FDA 510(k)

CAPD COLOR-GUARD SYSTEM PREPKIT

K-Number: K830002 · 1983-03-11

ApplicantAbbott Laboratories
Decision Date1983-03-11
Product CodeFKY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CAPD COLOR-GUARD SYSTEM PREPKIT is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1983-03-11 under 510(k) number K830002. The device is classified under product code FKY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPD COLOR-GUARD SYSTEM PREPKIT?

CAPD COLOR-GUARD SYSTEM PREPKIT is a medical device that received FDA 510(k) clearance on 1983-03-11. The listed applicant is Abbott Laboratories. The 510(k) number is K830002.

When did CAPD COLOR-GUARD SYSTEM PREPKIT receive FDA 510(k) clearance?

CAPD COLOR-GUARD SYSTEM PREPKIT received FDA 510(k) clearance on 1983-03-11, under 510(k) number K830002.

Who is the listed applicant for CAPD COLOR-GUARD SYSTEM PREPKIT?

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 CAPD COLOR-GUARD SYSTEM PREPKIT?

The FDA product code for CAPD COLOR-GUARD SYSTEM PREPKIT is FKY.

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Related Devices (Code: FKY)

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.

K991003PUMP SEGMENT RINSE LINE W/ SLIP-ON CONNECTOR, PUMP SEGMENT RINSE LINE W/ LUER-LOCK CONNECTOR, T-CONNECTOR, SHORT, W/ SLIDayspring Medical, Inc.K862722TUBING CONNECTOR #10-810-60 100/PKG NON-STERILEMercury Enterprises, Inc.K771428TENCKHOFF PERITONEAL TUBING ADAPT.Quinton, 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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