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FDA 510(k)

DOCUMENT ENZYME

K-Number: K932458 · 1993-06-29

ApplicantCasco Standards
Decision Date1993-06-29
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DOCUMENT ENZYME is the device name listed in this FDA 510(k) record. The listed applicant is Casco Standards. It received FDA 510(k) clearance on 1993-06-29 under 510(k) number K932458. 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 ENZYME?

DOCUMENT ENZYME is a medical device that received FDA 510(k) clearance on 1993-06-29. The listed applicant is Casco Standards. The 510(k) number is K932458.

When did DOCUMENT ENZYME receive FDA 510(k) clearance?

DOCUMENT ENZYME received FDA 510(k) clearance on 1993-06-29, under 510(k) number K932458.

Who is the listed applicant for DOCUMENT ENZYME?

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 ENZYME?

The FDA product code for DOCUMENT ENZYME 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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