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FDA 510(k)

B. FRAGTEX

K-Number: K881380 · 1988-10-06

ApplicantAmerican Biomedical Products, Inc.
Decision Date1988-10-06
Product CodeJSP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

B. FRAGTEX is the device name listed in this FDA 510(k) record. The listed applicant is American Biomedical Products, Inc.. It received FDA 510(k) clearance on 1988-10-06 under 510(k) number K881380. The device is classified under product code JSP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the B. FRAGTEX?

B. FRAGTEX is a medical device that received FDA 510(k) clearance on 1988-10-06. The listed applicant is American Biomedical Products, Inc.. The 510(k) number is K881380.

When did B. FRAGTEX receive FDA 510(k) clearance?

B. FRAGTEX received FDA 510(k) clearance on 1988-10-06, under 510(k) number K881380.

Who is the listed applicant for B. FRAGTEX?

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

What is the FDA product code for B. FRAGTEX?

The FDA product code for B. FRAGTEX is JSP.

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Related Devices (Code: JSP)

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.

K945488LYFO(TM) DIFFERENTIAL DISKMicrobiologics, Inc.K945487LYFO(TM) DIFFERENTIAL DISKMicrobiologics, Inc.K945489LYFO(TM) DIFFERENTIAL DISKMicrobiologics, Inc.K944528BBLCRYSTAL ANAEROBE ID SYSTEMBecton Dickinson Microbiology SystemsK910666VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATIONVitek Systems, Inc.K900996VITEK ANAEROBE IDENTIFICATION CARDVitek Systems, 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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