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FDA 510(k)

HEP-2 CELLS

K-Number: K831681 · 1983-07-06

ApplicantViromed Laboratories, Inc.
Decision Date1983-07-06
Product CodeKIR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEP-2 CELLS is the device name listed in this FDA 510(k) record. The listed applicant is Viromed Laboratories, Inc.. It received FDA 510(k) clearance on 1983-07-06 under 510(k) number K831681. The device is classified under product code KIR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEP-2 CELLS?

HEP-2 CELLS is a medical device that received FDA 510(k) clearance on 1983-07-06. The listed applicant is Viromed Laboratories, Inc.. The 510(k) number is K831681.

When did HEP-2 CELLS receive FDA 510(k) clearance?

HEP-2 CELLS received FDA 510(k) clearance on 1983-07-06, under 510(k) number K831681.

Who is the listed applicant for HEP-2 CELLS?

The FDA 510(k) record lists Viromed Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEP-2 CELLS?

The FDA product code for HEP-2 CELLS is KIR.

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Other records listing Viromed Laboratories, Inc. as applicant

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Related Devices (Code: KIR)

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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