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FDA 510(k)

TDM I LINEARITY TEST SET

K-Number: K913309 · 1991-09-13

ApplicantCasco Standards
Decision Date1991-09-13
Product CodeDIF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

TDM I LINEARITY TEST SET is the device name listed in this FDA 510(k) record. The listed applicant is Casco Standards. It received FDA 510(k) clearance on 1991-09-13 under 510(k) number K913309. The device is classified under product code DIF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TDM I LINEARITY TEST SET?

TDM I LINEARITY TEST SET is a medical device that received FDA 510(k) clearance on 1991-09-13. The listed applicant is Casco Standards. The 510(k) number is K913309.

When did TDM I LINEARITY TEST SET receive FDA 510(k) clearance?

TDM I LINEARITY TEST SET received FDA 510(k) clearance on 1991-09-13, under 510(k) number K913309.

Who is the listed applicant for TDM I LINEARITY TEST SET?

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

What is the FDA product code for TDM I LINEARITY TEST SET?

The FDA product code for TDM I LINEARITY TEST SET is DIF.

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Other records listing Casco Standards 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.

K981436DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109K972904DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROLK962629DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATORK961750DOCUMENT CARDIAC ASSAYED CONTROLK962630DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROLK960244DOCUMENT TDM ULTRA ASSAYED CONTROL

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Related Devices (Code: DIF)

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.

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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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