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FDA 510(k)

TSH - THIRD GENERATION LOW CONTROLS

K-Number: K924675 · 1992-11-18

ApplicantNichols Institute
Decision Date1992-11-18
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TSH - THIRD GENERATION LOW CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Nichols Institute. It received FDA 510(k) clearance on 1992-11-18 under 510(k) number K924675. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TSH - THIRD GENERATION LOW CONTROLS?

TSH - THIRD GENERATION LOW CONTROLS is a medical device that received FDA 510(k) clearance on 1992-11-18. The listed applicant is Nichols Institute. The 510(k) number is K924675.

When did TSH - THIRD GENERATION LOW CONTROLS receive FDA 510(k) clearance?

TSH - THIRD GENERATION LOW CONTROLS received FDA 510(k) clearance on 1992-11-18, under 510(k) number K924675.

Who is the listed applicant for TSH - THIRD GENERATION LOW CONTROLS?

The FDA 510(k) record lists Nichols Institute as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TSH - THIRD GENERATION LOW CONTROLS?

The FDA product code for TSH - THIRD GENERATION LOW CONTROLS is JJX.

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Other records listing Nichols Institute 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.

K952559ERYTHROPOIETIN IMMUNOASSAY KITK952505INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA)K946247IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3K950524NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAYK932650ERYTHROPOIETIN IMMUNOASSAY KITK931600CHEMILUMINESCENCE FREE T3 IMMUNOASSAY

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Related Devices (Code: JJX)

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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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