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FDA 510(k)

DOCUMENT TOTAL AND DIRECT BILIRUBIN LINEARITY-MOD

K-Number: K924493 · 1993-01-11

ApplicantCasco Standards
Decision Date1993-01-11
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DOCUMENT TOTAL AND DIRECT BILIRUBIN LINEARITY-MOD is the device name listed in this FDA 510(k) record. The listed applicant is Casco Standards. It received FDA 510(k) clearance on 1993-01-11 under 510(k) number K924493. 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 DOCUMENT TOTAL AND DIRECT BILIRUBIN LINEARITY-MOD?

DOCUMENT TOTAL AND DIRECT BILIRUBIN LINEARITY-MOD is a medical device that received FDA 510(k) clearance on 1993-01-11. The listed applicant is Casco Standards. The 510(k) number is K924493.

When did DOCUMENT TOTAL AND DIRECT BILIRUBIN LINEARITY-MOD receive FDA 510(k) clearance?

DOCUMENT TOTAL AND DIRECT BILIRUBIN LINEARITY-MOD received FDA 510(k) clearance on 1993-01-11, under 510(k) number K924493.

Who is the listed applicant for DOCUMENT TOTAL AND DIRECT BILIRUBIN LINEARITY-MOD?

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 DOCUMENT TOTAL AND DIRECT BILIRUBIN LINEARITY-MOD?

The FDA product code for DOCUMENT TOTAL AND DIRECT BILIRUBIN LINEARITY-MOD is 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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