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FDA 510(k)

PEGASYS INTOUCH

K-Number: K974474 · 1998-02-24

ApplicantAdac Laboratories
Decision Date1998-02-24
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PEGASYS INTOUCH is the device name listed in this FDA 510(k) record. The listed applicant is Adac Laboratories. It received FDA 510(k) clearance on 1998-02-24 under 510(k) number K974474. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEGASYS INTOUCH?

PEGASYS INTOUCH is a medical device that received FDA 510(k) clearance on 1998-02-24. The listed applicant is Adac Laboratories. The 510(k) number is K974474.

When did PEGASYS INTOUCH receive FDA 510(k) clearance?

PEGASYS INTOUCH received FDA 510(k) clearance on 1998-02-24, under 510(k) number K974474.

Who is the listed applicant for PEGASYS INTOUCH?

The FDA 510(k) record lists Adac Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PEGASYS INTOUCH?

The FDA product code for PEGASYS INTOUCH is LLZ.

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Other records listing Adac Laboratories 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.

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Related Devices (Code: LLZ)

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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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