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FDA 510(k)

BIO SURE STAIN

K-Number: K832496 · 1983-09-12

ApplicantHelena Laboratories
Decision Date1983-09-12
Product CodeIDA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BIO SURE STAIN is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1983-09-12 under 510(k) number K832496. The device is classified under product code IDA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO SURE STAIN?

BIO SURE STAIN is a medical device that received FDA 510(k) clearance on 1983-09-12. The listed applicant is Helena Laboratories. The 510(k) number is K832496.

When did BIO SURE STAIN receive FDA 510(k) clearance?

BIO SURE STAIN received FDA 510(k) clearance on 1983-09-12, under 510(k) number K832496.

Who is the listed applicant for BIO SURE STAIN?

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 BIO SURE STAIN?

The FDA product code for BIO SURE STAIN is IDA.

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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: IDA)

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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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