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FDA 510(k)

LABILE LYSING REAGENT

K-Number: K884315 · 1988-12-27

ApplicantHelena Laboratories
Decision Date1988-12-27
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

LABILE LYSING REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1988-12-27 under 510(k) number K884315. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LABILE LYSING REAGENT?

LABILE LYSING REAGENT is a medical device that received FDA 510(k) clearance on 1988-12-27. The listed applicant is Helena Laboratories. The 510(k) number is K884315.

When did LABILE LYSING REAGENT receive FDA 510(k) clearance?

LABILE LYSING REAGENT received FDA 510(k) clearance on 1988-12-27, under 510(k) number K884315.

Who is the listed applicant for LABILE LYSING REAGENT?

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 LABILE LYSING REAGENT?

The FDA product code for LABILE LYSING REAGENT is LCP.

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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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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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