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FDA 510(k)

DOCUMENT(TM) CHOLESTEROL CALIBRATOR SET

K-Number: K884197 · 1988-12-14

ApplicantCasco Standards
Decision Date1988-12-14
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DOCUMENT(TM) CHOLESTEROL CALIBRATOR 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 1988-12-14 under 510(k) number K884197. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOCUMENT(TM) CHOLESTEROL CALIBRATOR SET?

DOCUMENT(TM) CHOLESTEROL CALIBRATOR SET is a medical device that received FDA 510(k) clearance on 1988-12-14. The listed applicant is Casco Standards. The 510(k) number is K884197.

When did DOCUMENT(TM) CHOLESTEROL CALIBRATOR SET receive FDA 510(k) clearance?

DOCUMENT(TM) CHOLESTEROL CALIBRATOR SET received FDA 510(k) clearance on 1988-12-14, under 510(k) number K884197.

Who is the listed applicant for DOCUMENT(TM) CHOLESTEROL CALIBRATOR 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 DOCUMENT(TM) CHOLESTEROL CALIBRATOR SET?

The FDA product code for DOCUMENT(TM) CHOLESTEROL CALIBRATOR SET is JIT.

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Related Devices (Code: JIT)

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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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