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FDA 510(k)

DOCUMENT R AMMONIA/ETHANOL CONTROL

K-Number: K944361 · 1994-11-30

ApplicantCasco Standards
Decision Date1994-11-30
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DOCUMENT R AMMONIA/ETHANOL CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Casco Standards. It received FDA 510(k) clearance on 1994-11-30 under 510(k) number K944361. 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 CONTROL?

DOCUMENT R AMMONIA/ETHANOL CONTROL is a medical device that received FDA 510(k) clearance on 1994-11-30. The listed applicant is Casco Standards. The 510(k) number is K944361.

When did DOCUMENT R AMMONIA/ETHANOL CONTROL receive FDA 510(k) clearance?

DOCUMENT R AMMONIA/ETHANOL CONTROL received FDA 510(k) clearance on 1994-11-30, under 510(k) number K944361.

Who is the listed applicant for DOCUMENT R AMMONIA/ETHANOL CONTROL?

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 CONTROL?

The FDA product code for DOCUMENT R AMMONIA/ETHANOL CONTROL 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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