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FDA 510(k)

KALLESTAD HEP-2 CELL LINE SUBSTRATE

K-Number: K810863 · 1981-04-14

ApplicantKallestad Laboratories, Inc.
Decision Date1981-04-14
Product CodeDBM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

KALLESTAD HEP-2 CELL LINE SUBSTRATE is the device name listed in this FDA 510(k) record. The listed applicant is Kallestad Laboratories, Inc.. It received FDA 510(k) clearance on 1981-04-14 under 510(k) number K810863. The device is classified under product code DBM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KALLESTAD HEP-2 CELL LINE SUBSTRATE?

KALLESTAD HEP-2 CELL LINE SUBSTRATE is a medical device that received FDA 510(k) clearance on 1981-04-14. The listed applicant is Kallestad Laboratories, Inc.. The 510(k) number is K810863.

When did KALLESTAD HEP-2 CELL LINE SUBSTRATE receive FDA 510(k) clearance?

KALLESTAD HEP-2 CELL LINE SUBSTRATE received FDA 510(k) clearance on 1981-04-14, under 510(k) number K810863.

Who is the listed applicant for KALLESTAD HEP-2 CELL LINE SUBSTRATE?

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

What is the FDA product code for KALLESTAD HEP-2 CELL LINE SUBSTRATE?

The FDA product code for KALLESTAD HEP-2 CELL LINE SUBSTRATE is DBM.

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Other records listing Kallestad Laboratories, Inc. as applicant

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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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