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FDA 510(k)

DADE ALCOHOL & AMMONIA CONTROLS LEVEL I-LOW & II H

K-Number: K850575 · 1985-04-10

ApplicantAmerican Dade
Decision Date1985-04-10
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DADE ALCOHOL & AMMONIA CONTROLS LEVEL I-LOW & II H is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1985-04-10 under 510(k) number K850575. 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 DADE ALCOHOL & AMMONIA CONTROLS LEVEL I-LOW & II H?

DADE ALCOHOL & AMMONIA CONTROLS LEVEL I-LOW & II H is a medical device that received FDA 510(k) clearance on 1985-04-10. The listed applicant is American Dade. The 510(k) number is K850575.

When did DADE ALCOHOL & AMMONIA CONTROLS LEVEL I-LOW & II H receive FDA 510(k) clearance?

DADE ALCOHOL & AMMONIA CONTROLS LEVEL I-LOW & II H received FDA 510(k) clearance on 1985-04-10, under 510(k) number K850575.

Who is the listed applicant for DADE ALCOHOL & AMMONIA CONTROLS LEVEL I-LOW & II H?

The FDA 510(k) record lists American Dade as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DADE ALCOHOL & AMMONIA CONTROLS LEVEL I-LOW & II H?

The FDA product code for DADE ALCOHOL & AMMONIA CONTROLS LEVEL I-LOW & II H is JJY.

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Other records listing American Dade 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.

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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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