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FDA 510(k)

THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME

K-Number: K932153 · 1993-09-07

ApplicantBiodan Medical Systems, Ltd.
Decision Date1993-09-07
Product CodeIZD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME is the device name listed in this FDA 510(k) record. The listed applicant is Biodan Medical Systems, Ltd.. It received FDA 510(k) clearance on 1993-09-07 under 510(k) number K932153. The device is classified under product code IZD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME?

THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME is a medical device that received FDA 510(k) clearance on 1993-09-07. The listed applicant is Biodan Medical Systems, Ltd.. The 510(k) number is K932153.

When did THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME receive FDA 510(k) clearance?

THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME received FDA 510(k) clearance on 1993-09-07, under 510(k) number K932153.

Who is the listed applicant for THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME?

The FDA 510(k) record lists Biodan Medical Systems, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME?

The FDA product code for THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME is IZD.

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Other records listing Biodan Medical Systems, Ltd. as applicant

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Related Devices (Code: IZD)

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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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