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FDA 510(k)

BIOTRACK PROTIME CONTROLS (BIOTRACK PROTIME TEST)

K-Number: K860719 · 1986-05-23

ApplicantBiotrack, Inc.
Decision Date1986-05-23
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BIOTRACK PROTIME CONTROLS (BIOTRACK PROTIME TEST) is the device name listed in this FDA 510(k) record. The listed applicant is Biotrack, Inc.. It received FDA 510(k) clearance on 1986-05-23 under 510(k) number K860719. 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 BIOTRACK PROTIME CONTROLS (BIOTRACK PROTIME TEST)?

BIOTRACK PROTIME CONTROLS (BIOTRACK PROTIME TEST) is a medical device that received FDA 510(k) clearance on 1986-05-23. The listed applicant is Biotrack, Inc.. The 510(k) number is K860719.

When did BIOTRACK PROTIME CONTROLS (BIOTRACK PROTIME TEST) receive FDA 510(k) clearance?

BIOTRACK PROTIME CONTROLS (BIOTRACK PROTIME TEST) received FDA 510(k) clearance on 1986-05-23, under 510(k) number K860719.

Who is the listed applicant for BIOTRACK PROTIME CONTROLS (BIOTRACK PROTIME TEST)?

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

What is the FDA product code for BIOTRACK PROTIME CONTROLS (BIOTRACK PROTIME TEST)?

The FDA product code for BIOTRACK PROTIME CONTROLS (BIOTRACK PROTIME TEST) is JPA.

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Other records listing Biotrack, Inc. as applicant

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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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