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FDA 510(k)

OPTIPHOR-10

K-Number: K842560 · 1984-08-10

ApplicantGelman Sciences, Inc.
Decision Date1984-08-10
Product CodeJJN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OPTIPHOR-10 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 1984-08-10 under 510(k) number K842560. The device is classified under product code JJN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTIPHOR-10?

OPTIPHOR-10 is a medical device that received FDA 510(k) clearance on 1984-08-10. The listed applicant is Gelman Sciences, Inc.. The 510(k) number is K842560.

When did OPTIPHOR-10 receive FDA 510(k) clearance?

OPTIPHOR-10 received FDA 510(k) clearance on 1984-08-10, under 510(k) number K842560.

Who is the listed applicant for OPTIPHOR-10?

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 OPTIPHOR-10?

The FDA product code for OPTIPHOR-10 is JJN.

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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: JJN)

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.

K924021POWER SUPPLYThe Binding Site, Ltd.K924020ELECTROPHORESIS TANKThe Binding Site, Ltd.K882344ELECTR-TRANSBLOTTERThe W.E.P. Co.K881852REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170Helena LaboratoriesK882163HELENA REP GEL PROCESSORHelena LaboratoriesK873352RAPID ELECTROPHORESIS SYSTEM (REP)Helena Laboratories

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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