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FDA 510(k)

DIGI TROL TM-RX & DIGI TROL TM-TX

K-Number: K770411 · 1977-03-16

ApplicantNuclear Medical Laboratories, Inc.
Decision Date1977-03-16
Product CodeDMP
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DIGI TROL TM-RX & DIGI TROL TM-TX is the device name listed in this FDA 510(k) record. The listed applicant is Nuclear Medical Laboratories, Inc.. It received FDA 510(k) clearance on 1977-03-16 under 510(k) number K770411. The device is classified under product code DMP. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGI TROL TM-RX & DIGI TROL TM-TX?

DIGI TROL TM-RX & DIGI TROL TM-TX is a medical device that received FDA 510(k) clearance on 1977-03-16. The listed applicant is Nuclear Medical Laboratories, Inc.. The 510(k) number is K770411.

When did DIGI TROL TM-RX & DIGI TROL TM-TX receive FDA 510(k) clearance?

DIGI TROL TM-RX & DIGI TROL TM-TX received FDA 510(k) clearance on 1977-03-16, under 510(k) number K770411.

Who is the listed applicant for DIGI TROL TM-RX & DIGI TROL TM-TX?

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

What is the FDA product code for DIGI TROL TM-RX & DIGI TROL TM-TX?

The FDA product code for DIGI TROL TM-RX & DIGI TROL TM-TX is DMP.

Other records listing Nuclear Medical Laboratories, 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.

K852438NML TSH IRMAK844583TSH-STATK840466NML CORTISOL RIAK840589TRI-TUBE RIAK832892MODIFIED CHORIO-SHUREK832002NML-5010/5020 MULTI-DETECTOR SYSTEM

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Related Devices (Code: DMP)

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.

K973973ELECSYS CALLCHECK DIGOXINBoehringer Mannheim Corp.K953393TOX PERFECT A TUBEChimera Research & Chemical, Inc.K780889DIGOXIN STANDARDS IN HUMAN SERUMPcl-Ria, 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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