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FDA 510(k)

UNIPAK 100 ANALYZER, 65156 & CHEMISTR

K-Number: K840883 · 1984-05-16

ApplicantEmd Chemicals, Inc.
Decision Date1984-05-16
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UNIPAK 100 ANALYZER, 65156 & CHEMISTR is the device name listed in this FDA 510(k) record. The listed applicant is Emd Chemicals, Inc.. It received FDA 510(k) clearance on 1984-05-16 under 510(k) number K840883. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIPAK 100 ANALYZER, 65156 & CHEMISTR?

UNIPAK 100 ANALYZER, 65156 & CHEMISTR is a medical device that received FDA 510(k) clearance on 1984-05-16. The listed applicant is Emd Chemicals, Inc.. The 510(k) number is K840883.

When did UNIPAK 100 ANALYZER, 65156 & CHEMISTR receive FDA 510(k) clearance?

UNIPAK 100 ANALYZER, 65156 & CHEMISTR received FDA 510(k) clearance on 1984-05-16, under 510(k) number K840883.

Who is the listed applicant for UNIPAK 100 ANALYZER, 65156 & CHEMISTR?

The FDA 510(k) record lists Emd Chemicals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNIPAK 100 ANALYZER, 65156 & CHEMISTR?

The FDA product code for UNIPAK 100 ANALYZER, 65156 & CHEMISTR is JJE.

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Other records listing Emd Chemicals, Inc. as applicant

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Related Devices (Code: JJE)

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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