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FDA 510(k)

V8 SP NORMAL CONTROL, ABNORMAL CONTROL

K-Number: K131479 · 2013-10-07

ApplicantHelena Laboratories
Decision Date2013-10-07
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

V8 SP NORMAL CONTROL, ABNORMAL CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 2013-10-07 under 510(k) number K131479. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the V8 SP NORMAL CONTROL, ABNORMAL CONTROL?

V8 SP NORMAL CONTROL, ABNORMAL CONTROL is a medical device that received FDA 510(k) clearance on 2013-10-07. The listed applicant is Helena Laboratories. The 510(k) number is K131479.

When did V8 SP NORMAL CONTROL, ABNORMAL CONTROL receive FDA 510(k) clearance?

V8 SP NORMAL CONTROL, ABNORMAL CONTROL received FDA 510(k) clearance on 2013-10-07, under 510(k) number K131479.

Who is the listed applicant for V8 SP NORMAL CONTROL, ABNORMAL CONTROL?

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 V8 SP NORMAL CONTROL, ABNORMAL CONTROL?

The FDA product code for V8 SP NORMAL CONTROL, ABNORMAL CONTROL is JJY.

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Related Devices (Code: JJY)

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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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