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FDA 510(k)

CASCASE 480 SNSLYZER

K-Number: K951497 · 1995-09-01

ApplicantHelena Laboratories
Decision Date1995-09-01
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CASCASE 480 SNSLYZER is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1995-09-01 under 510(k) number K951497. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CASCASE 480 SNSLYZER?

CASCASE 480 SNSLYZER is a medical device that received FDA 510(k) clearance on 1995-09-01. The listed applicant is Helena Laboratories. The 510(k) number is K951497.

When did CASCASE 480 SNSLYZER receive FDA 510(k) clearance?

CASCASE 480 SNSLYZER received FDA 510(k) clearance on 1995-09-01, under 510(k) number K951497.

Who is the listed applicant for CASCASE 480 SNSLYZER?

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

What is the FDA product code for CASCASE 480 SNSLYZER?

The FDA product code for CASCASE 480 SNSLYZER is JPA.

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Other records listing Helena 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: JPA)

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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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