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FDA 510(k)

TDX AMYLASE

K-Number: K853978 · 1985-10-15

ApplicantAbbott Laboratories
Decision Date1985-10-15
Product CodeCIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TDX AMYLASE is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1985-10-15 under 510(k) number K853978. The device is classified under product code CIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TDX AMYLASE?

TDX AMYLASE is a medical device that received FDA 510(k) clearance on 1985-10-15. The listed applicant is Abbott Laboratories. The 510(k) number is K853978.

When did TDX AMYLASE receive FDA 510(k) clearance?

TDX AMYLASE received FDA 510(k) clearance on 1985-10-15, under 510(k) number K853978.

Who is the listed applicant for TDX AMYLASE?

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

What is the FDA product code for TDX AMYLASE?

The FDA product code for TDX AMYLASE is CIX.

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Related Devices (Code: CIX)

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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