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FDA 510(k)

CHROMATOGRAPHY KIT

K-Number: K884176 · 1989-04-04

ApplicantGelman Sciences, Inc.
Decision Date1989-04-04
Product CodeDPA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHROMATOGRAPHY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Gelman Sciences, Inc.. It received FDA 510(k) clearance on 1989-04-04 under 510(k) number K884176. The device is classified under product code DPA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHROMATOGRAPHY KIT?

CHROMATOGRAPHY KIT is a medical device that received FDA 510(k) clearance on 1989-04-04. The listed applicant is Gelman Sciences, Inc.. The 510(k) number is K884176.

When did CHROMATOGRAPHY KIT receive FDA 510(k) clearance?

CHROMATOGRAPHY KIT received FDA 510(k) clearance on 1989-04-04, under 510(k) number K884176.

Who is the listed applicant for CHROMATOGRAPHY KIT?

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

What is the FDA product code for CHROMATOGRAPHY KIT?

The FDA product code for CHROMATOGRAPHY KIT is DPA.

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Other records listing Gelman Sciences, Inc. 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.

K946190DRUG DISPENSING SPIKEK943127PHARMASSURE LARGE VOLUME TRANSFER FILTERSK941589SYRINGE FILTER DEVICESK941020DRUG RECONSTITUTION FILTER DEVICEK942275VIAL VENT FILTERK941032UNKNOWN

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Related Devices (Code: DPA)

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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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