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FDA 510(k)

DUPLOJECT (0.5/1.0 ML, 2.0 ML, 5.0 ML)

K-Number: K973510 · 1997-12-08

ApplicantImmuno-U.S., Inc.
Decision Date1997-12-08
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DUPLOJECT (0.5/1.0 ML, 2.0 ML, 5.0 ML) is the device name listed in this FDA 510(k) record. The listed applicant is Immuno-U.S., Inc.. It received FDA 510(k) clearance on 1997-12-08 under 510(k) number K973510. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUPLOJECT (0.5/1.0 ML, 2.0 ML, 5.0 ML)?

DUPLOJECT (0.5/1.0 ML, 2.0 ML, 5.0 ML) is a medical device that received FDA 510(k) clearance on 1997-12-08. The listed applicant is Immuno-U.S., Inc.. The 510(k) number is K973510.

When did DUPLOJECT (0.5/1.0 ML, 2.0 ML, 5.0 ML) receive FDA 510(k) clearance?

DUPLOJECT (0.5/1.0 ML, 2.0 ML, 5.0 ML) received FDA 510(k) clearance on 1997-12-08, under 510(k) number K973510.

Who is the listed applicant for DUPLOJECT (0.5/1.0 ML, 2.0 ML, 5.0 ML)?

The FDA 510(k) record lists Immuno-U.S., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DUPLOJECT (0.5/1.0 ML, 2.0 ML, 5.0 ML)?

The FDA product code for DUPLOJECT (0.5/1.0 ML, 2.0 ML, 5.0 ML) is FMF.

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Related Devices (Code: FMF)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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