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FDA 510(k)

DOCUMENT R AMMONIA / ETHANOL CALIBRATION VERIFICATION REST SET

K-Number: K944338 · 1994-11-15

ApplicantCasco Standards
Decision Date1994-11-15
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DOCUMENT R AMMONIA / ETHANOL CALIBRATION VERIFICATION REST 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 1994-11-15 under 510(k) number K944338. 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 R AMMONIA / ETHANOL CALIBRATION VERIFICATION REST SET?

DOCUMENT R AMMONIA / ETHANOL CALIBRATION VERIFICATION REST SET is a medical device that received FDA 510(k) clearance on 1994-11-15. The listed applicant is Casco Standards. The 510(k) number is K944338.

When did DOCUMENT R AMMONIA / ETHANOL CALIBRATION VERIFICATION REST SET receive FDA 510(k) clearance?

DOCUMENT R AMMONIA / ETHANOL CALIBRATION VERIFICATION REST SET received FDA 510(k) clearance on 1994-11-15, under 510(k) number K944338.

Who is the listed applicant for DOCUMENT R AMMONIA / ETHANOL CALIBRATION VERIFICATION REST 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 R AMMONIA / ETHANOL CALIBRATION VERIFICATION REST SET?

The FDA product code for DOCUMENT R AMMONIA / ETHANOL CALIBRATION VERIFICATION REST SET is JJX.

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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: 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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