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FDA 510(k)

NORMAL AND ABNORMAL CONTROL SERA

K-Number: K895943 · 1989-12-27

ApplicantSclavo, Inc.
Decision Date1989-12-27
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NORMAL AND ABNORMAL CONTROL SERA is the device name listed in this FDA 510(k) record. The listed applicant is Sclavo, Inc.. It received FDA 510(k) clearance on 1989-12-27 under 510(k) number K895943. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NORMAL AND ABNORMAL CONTROL SERA?

NORMAL AND ABNORMAL CONTROL SERA is a medical device that received FDA 510(k) clearance on 1989-12-27. The listed applicant is Sclavo, Inc.. The 510(k) number is K895943.

When did NORMAL AND ABNORMAL CONTROL SERA receive FDA 510(k) clearance?

NORMAL AND ABNORMAL CONTROL SERA received FDA 510(k) clearance on 1989-12-27, under 510(k) number K895943.

Who is the listed applicant for NORMAL AND ABNORMAL CONTROL SERA?

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

What is the FDA product code for NORMAL AND ABNORMAL CONTROL SERA?

The FDA product code for NORMAL AND ABNORMAL CONTROL SERA is JJY.

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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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