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FDA 510(k)

TEK-PRO TEK-TATOR V ROTATOR & HUMIDIFY

K-Number: K820043 · 1982-01-28

ApplicantAmerican Dade
Decision Date1982-01-28
Product CodeLIB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TEK-PRO TEK-TATOR V ROTATOR & HUMIDIFY is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1982-01-28 under 510(k) number K820043. The device is classified under product code LIB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEK-PRO TEK-TATOR V ROTATOR & HUMIDIFY?

TEK-PRO TEK-TATOR V ROTATOR & HUMIDIFY is a medical device that received FDA 510(k) clearance on 1982-01-28. The listed applicant is American Dade. The 510(k) number is K820043.

When did TEK-PRO TEK-TATOR V ROTATOR & HUMIDIFY receive FDA 510(k) clearance?

TEK-PRO TEK-TATOR V ROTATOR & HUMIDIFY received FDA 510(k) clearance on 1982-01-28, under 510(k) number K820043.

Who is the listed applicant for TEK-PRO TEK-TATOR V ROTATOR & HUMIDIFY?

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 TEK-PRO TEK-TATOR V ROTATOR & HUMIDIFY?

The FDA product code for TEK-PRO TEK-TATOR V ROTATOR & HUMIDIFY is LIB.

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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.

K873051STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAYK873171STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAYK873052STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAYK872789PARAMAX URINE/CSF CALIBRATORK872195DATA-FI DIMERTEST LATEX ASSAYK872196AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III

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Related Devices (Code: LIB)

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.

K023677OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV)OsmetechK920416SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMBBehring Diagnostics, Inc.K912558GULL ELISAWAREGull Laboratories, Inc.K872273CORNING EASY WASH ELISA PLATESCorning Medical & ScientificK871559CELL LIFTERCorning Costar Corp.K864249NORMAL SALINE STERILEMds Laboratories, 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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