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FDA 510(k)

HELENA BIOSTRIP PH

K-Number: K830979 · 1983-05-05

ApplicantHelena Laboratories
Decision Date1983-05-05
Product CodeCEN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HELENA BIOSTRIP PH is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1983-05-05 under 510(k) number K830979. The device is classified under product code CEN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HELENA BIOSTRIP PH?

HELENA BIOSTRIP PH is a medical device that received FDA 510(k) clearance on 1983-05-05. The listed applicant is Helena Laboratories. The 510(k) number is K830979.

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

HELENA BIOSTRIP PH received FDA 510(k) clearance on 1983-05-05, under 510(k) number K830979.

Who is the listed applicant for HELENA BIOSTRIP PH?

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 PH?

The FDA product code for HELENA BIOSTRIP PH is CEN.

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Other records listing Helena Laboratories as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: CEN)

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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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