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FDA 510(k)

HELENA BIOSTRIP P

K-Number: K830977 · 1983-04-28

ApplicantHelena Laboratories
Decision Date1983-04-28
Product CodeJIR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HELENA BIOSTRIP P is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1983-04-28 under 510(k) number K830977. The device is classified under product code JIR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HELENA BIOSTRIP P?

HELENA BIOSTRIP P is a medical device that received FDA 510(k) clearance on 1983-04-28. The listed applicant is Helena Laboratories. The 510(k) number is K830977.

When did HELENA BIOSTRIP P receive FDA 510(k) clearance?

HELENA BIOSTRIP P received FDA 510(k) clearance on 1983-04-28, under 510(k) number K830977.

Who is the listed applicant for HELENA BIOSTRIP P?

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 HELENA BIOSTRIP P?

The FDA product code for HELENA BIOSTRIP P is JIR.

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Other records listing Helena Laboratories as applicant

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Related Devices (Code: JIR)

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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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