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FDA 510(k)

TOBRAM E.R.A. TM

K-Number: K800517 · 1980-03-20

ApplicantP-L Biochemicals, Inc.
Decision Date1980-03-20
Product CodeKLQ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

TOBRAM E.R.A. TM is the device name listed in this FDA 510(k) record. The listed applicant is P-L Biochemicals, Inc.. It received FDA 510(k) clearance on 1980-03-20 under 510(k) number K800517. The device is classified under product code KLQ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOBRAM E.R.A. TM?

TOBRAM E.R.A. TM is a medical device that received FDA 510(k) clearance on 1980-03-20. The listed applicant is P-L Biochemicals, Inc.. The 510(k) number is K800517.

When did TOBRAM E.R.A. TM receive FDA 510(k) clearance?

TOBRAM E.R.A. TM received FDA 510(k) clearance on 1980-03-20, under 510(k) number K800517.

Who is the listed applicant for TOBRAM E.R.A. TM?

The FDA 510(k) record lists P-L Biochemicals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOBRAM E.R.A. TM?

The FDA product code for TOBRAM E.R.A. TM is KLQ.

Related Clinical Trials

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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Other records listing P-L Biochemicals, Inc. 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.

K813449PHE/TYR KINETIC UV TEST SET

Related Devices (Code: KLQ)

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.

K052815QMS AMIKACIN REAGENTSSeradyn, Inc.K033884RANDOX AMIKACINRandox Laboratories, Ltd.K955570INNOFLUOR AMIKACIN ASSAY SYSTEMOxis Intl., Inc.K903100INNOFLUOR (TM) AMIKACIN REAGENT SETInnotron of Oregon, Inc.K894517FPR AMIKACIN KITColony Laboratories, Inc.K852317COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATORRoche Diagnostic 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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