FDA 510(k)

ABC, ABC-1X, ABC(TM)

K-Number: K890482 · 1989-02-10

Decision Date1989-02-10

Product CodeKIT

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

ABC, ABC-1X, ABC(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Cell Ent., Inc.. It received FDA 510(k) clearance on 1989-02-10 under 510(k) number K890482. The device is classified under product code KIT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABC, ABC-1X, ABC(TM)?

ABC, ABC-1X, ABC(TM) is a medical device that received FDA 510(k) clearance on 1989-02-10. The listed applicant is Cell Ent., Inc.. The 510(k) number is K890482.

When did ABC, ABC-1X, ABC(TM) receive FDA 510(k) clearance?

ABC, ABC-1X, ABC(TM) received FDA 510(k) clearance on 1989-02-10, under 510(k) number K890482.

Who is the listed applicant for ABC, ABC-1X, ABC(TM)?

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

What is the FDA product code for ABC, ABC-1X, ABC(TM)?

The FDA product code for ABC, ABC-1X, ABC(TM) is KIT.

Related Devices (Code: KIT)

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.

K892938AMNIO-GROW TMInovar Biologicals, Inc.K890700MELANOCYTE GROWTH MEDIUM (MGM)Clonetics Corp.K890701ENDOTHELIAL GROWTH MEDIUM (EGM)Clonetics Corp.K884654ALPHACALF SERUMHyclone Laboratories, Inc.K884572RPMI-1640 HYBRI-MAX, PROD. NO. R5382Sigma Chemical Co.K884574DME & HAM'S NUTRIENT MIXTURE, PROD. NO. D9785Sigma Chemical Co.

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.