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FDA 510(k)

THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451

K-Number: K961908 · 1996-12-10

ApplicantHelena Laboratories
Decision Date1996-12-10
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451 is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1996-12-10 under 510(k) number K961908. 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 THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451?

THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451 is a medical device that received FDA 510(k) clearance on 1996-12-10. The listed applicant is Helena Laboratories. The 510(k) number is K961908.

When did THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451 receive FDA 510(k) clearance?

THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451 received FDA 510(k) clearance on 1996-12-10, under 510(k) number K961908.

Who is the listed applicant for THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451?

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 THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451?

The FDA product code for THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451 is JPA.

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Other records listing Helena Laboratories as applicant

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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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