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FDA 510(k)

DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROL

K-Number: K962630 · 1996-07-22

ApplicantCasco Standards
Decision Date1996-07-22
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED 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 1996-07-22 under 510(k) number K962630. 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 AMMONIA, ETHANOL, LACTATE ASSAYED CONTROL?

DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROL is a medical device that received FDA 510(k) clearance on 1996-07-22. The listed applicant is Casco Standards. The 510(k) number is K962630.

When did DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROL receive FDA 510(k) clearance?

DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROL received FDA 510(k) clearance on 1996-07-22, under 510(k) number K962630.

Who is the listed applicant for DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED 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 AMMONIA, ETHANOL, LACTATE ASSAYED CONTROL?

The FDA product code for DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED 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 CONTROLK960244DOCUMENT TDM ULTRA ASSAYED CONTROLK955155DOCUMENT TDM ULTRA UNASSAYED CONTROL

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Related Devices (Code: JJY)

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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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