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FDA 510(k)

UNI PAK 500 ANALYZER + CHEMISTRY REAGENT ITEM

K-Number: K852481 · 1985-08-21

ApplicantEm Diagnostic Systems, Inc.
Decision Date1985-08-21
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UNI PAK 500 ANALYZER + CHEMISTRY REAGENT ITEM is the device name listed in this FDA 510(k) record. The listed applicant is Em Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1985-08-21 under 510(k) number K852481. The device is classified under product code JJQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNI PAK 500 ANALYZER + CHEMISTRY REAGENT ITEM?

UNI PAK 500 ANALYZER + CHEMISTRY REAGENT ITEM is a medical device that received FDA 510(k) clearance on 1985-08-21. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K852481.

When did UNI PAK 500 ANALYZER + CHEMISTRY REAGENT ITEM receive FDA 510(k) clearance?

UNI PAK 500 ANALYZER + CHEMISTRY REAGENT ITEM received FDA 510(k) clearance on 1985-08-21, under 510(k) number K852481.

Who is the listed applicant for UNI PAK 500 ANALYZER + CHEMISTRY REAGENT ITEM?

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

What is the FDA product code for UNI PAK 500 ANALYZER + CHEMISTRY REAGENT ITEM?

The FDA product code for UNI PAK 500 ANALYZER + CHEMISTRY REAGENT ITEM is JJQ.

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Other records listing Em Diagnostic Systems, Inc. as applicant

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Related Devices (Code: JJQ)

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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