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FDA 510(k)

DOCUMENT(R) AMMONIA/ETHANOL AQUEOUS CONTROL

K-Number: K945315 · 1994-12-09

ApplicantCasco Standards
Decision Date1994-12-09
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DOCUMENT(R) AMMONIA/ETHANOL AQUEOUS 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 1994-12-09 under 510(k) number K945315. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOCUMENT(R) AMMONIA/ETHANOL AQUEOUS CONTROL?

DOCUMENT(R) AMMONIA/ETHANOL AQUEOUS CONTROL is a medical device that received FDA 510(k) clearance on 1994-12-09. The listed applicant is Casco Standards. The 510(k) number is K945315.

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

DOCUMENT(R) AMMONIA/ETHANOL AQUEOUS CONTROL received FDA 510(k) clearance on 1994-12-09, under 510(k) number K945315.

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

The FDA product code for DOCUMENT(R) AMMONIA/ETHANOL AQUEOUS CONTROL is JJY.

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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: JJY)

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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