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FDA 510(k)

PDA699/PDA700 PROTAMINE DOSE ASSAY FOR HEP. NEUTRA

K-Number: K870831 · 1987-06-01

ApplicantInternational Technidyne Corp.
Decision Date1987-06-01
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PDA699/PDA700 PROTAMINE DOSE ASSAY FOR HEP. NEUTRA is the device name listed in this FDA 510(k) record. The listed applicant is International Technidyne Corp.. It received FDA 510(k) clearance on 1987-06-01 under 510(k) number K870831. 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 PDA699/PDA700 PROTAMINE DOSE ASSAY FOR HEP. NEUTRA?

PDA699/PDA700 PROTAMINE DOSE ASSAY FOR HEP. NEUTRA is a medical device that received FDA 510(k) clearance on 1987-06-01. The listed applicant is International Technidyne Corp.. The 510(k) number is K870831.

When did PDA699/PDA700 PROTAMINE DOSE ASSAY FOR HEP. NEUTRA receive FDA 510(k) clearance?

PDA699/PDA700 PROTAMINE DOSE ASSAY FOR HEP. NEUTRA received FDA 510(k) clearance on 1987-06-01, under 510(k) number K870831.

Who is the listed applicant for PDA699/PDA700 PROTAMINE DOSE ASSAY FOR HEP. NEUTRA?

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

What is the FDA product code for PDA699/PDA700 PROTAMINE DOSE ASSAY FOR HEP. NEUTRA?

The FDA product code for PDA699/PDA700 PROTAMINE DOSE ASSAY FOR HEP. NEUTRA is 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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