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FDA 510(k)

TEST SET, 125 I-DIGOXIN

K-Number: K781834 · 1979-01-03

ApplicantWien Laboratories, Inc.
Decision Date1979-01-03
Product CodeDNL
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

TEST SET, 125 I-DIGOXIN is the device name listed in this FDA 510(k) record. The listed applicant is Wien Laboratories, Inc.. It received FDA 510(k) clearance on 1979-01-03 under 510(k) number K781834. The device is classified under product code DNL. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEST SET, 125 I-DIGOXIN?

TEST SET, 125 I-DIGOXIN is a medical device that received FDA 510(k) clearance on 1979-01-03. The listed applicant is Wien Laboratories, Inc.. The 510(k) number is K781834.

When did TEST SET, 125 I-DIGOXIN receive FDA 510(k) clearance?

TEST SET, 125 I-DIGOXIN received FDA 510(k) clearance on 1979-01-03, under 510(k) number K781834.

Who is the listed applicant for TEST SET, 125 I-DIGOXIN?

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

What is the FDA product code for TEST SET, 125 I-DIGOXIN?

The FDA product code for TEST SET, 125 I-DIGOXIN is DNL.

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Other records listing Wien 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.

K912850SHBGK834246PROGESTERONE TEST SET 125I 17-OHK832452ANDROSTENEDIONE TEST SET 125IK823200125 I-DEHYDROEPIANDROSTERONE SULFATEK821652DOXEPIN TRI-CY TEST SETK821653PROTRIPTYLINE TRI-CY TEST SET

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Related Devices (Code: DNL)

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.

K852343DIG RADIOIMMUNOASSAY TEST SYSTEMM Nobird, Inc.K852291TIPSEP DIGOXIN RIANuclear Diagnostics, Inc.K811212DIGOXIN (RIA) KITImmuno Assay Corp.K810966DIAGOXIN SQUIBB RADIOIMMUNOASSAY KITE. R. Squibb & Sons, Inc.K802841DIGOXIN RADIOIMMUNOASSAY KITAmerican Diagnostic Corp.K781495RIANEN ASSAY SYSTEM, 125I KITNew England Nuclear

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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