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FDA 510(k)

MODIFIED UNISCEPT KB LABELING AMENDMENT

K-Number: K861408 · 1986-05-16

ApplicantAnalytab Products, Inc.
Decision Date1986-05-16
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MODIFIED UNISCEPT KB LABELING AMENDMENT is the device name listed in this FDA 510(k) record. The listed applicant is Analytab Products, Inc.. It received FDA 510(k) clearance on 1986-05-16 under 510(k) number K861408. The device is classified under product code JWY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED UNISCEPT KB LABELING AMENDMENT?

MODIFIED UNISCEPT KB LABELING AMENDMENT is a medical device that received FDA 510(k) clearance on 1986-05-16. The listed applicant is Analytab Products, Inc.. The 510(k) number is K861408.

When did MODIFIED UNISCEPT KB LABELING AMENDMENT receive FDA 510(k) clearance?

MODIFIED UNISCEPT KB LABELING AMENDMENT received FDA 510(k) clearance on 1986-05-16, under 510(k) number K861408.

Who is the listed applicant for MODIFIED UNISCEPT KB LABELING AMENDMENT?

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

What is the FDA product code for MODIFIED UNISCEPT KB LABELING AMENDMENT?

The FDA product code for MODIFIED UNISCEPT KB LABELING AMENDMENT is JWY.

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Other records listing Analytab Products, Inc. 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.

K912965API UNISCEPT KBK912964API UNISCEPT MIC/UNISCEPT MICRO-MICK812877PENASEK812862API GERM TUBE

Related Devices (Code: JWY)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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