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FDA 510(k)

ACRODISC

K-Number: K810829 · 1981-04-08

ApplicantGelman Sciences, Inc.
Decision Date1981-04-08
Product CodeJRL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACRODISC 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 1981-04-08 under 510(k) number K810829. The device is classified under product code JRL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACRODISC?

ACRODISC is a medical device that received FDA 510(k) clearance on 1981-04-08. The listed applicant is Gelman Sciences, Inc.. The 510(k) number is K810829.

When did ACRODISC receive FDA 510(k) clearance?

ACRODISC received FDA 510(k) clearance on 1981-04-08, under 510(k) number K810829.

Who is the listed applicant for ACRODISC?

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 ACRODISC?

The FDA product code for ACRODISC is JRL.

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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: JRL)

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.

K822121ACRO PACKGelman Sciences, Inc.K820455CENTRIFREE MICROPARTITION SYSTEMAmicon, Inc.K820224EMIT FREELEVEL SYSTEM ISyva Co.K812750IL 703, STAT SEPARATORInstrumentation Laboratory COK813159VACUSHIELD TMGelman Sciences, Inc.K801500ULTRAFREE CALCIUM FILTERMillipore Corp.

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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