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FDA 510(k)

API GERM TUBE

K-Number: K812862 · 1981-10-26

ApplicantAnalytab Products, Inc.
Decision Date1981-10-26
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

API GERM TUBE 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 1981-10-26 under 510(k) number K812862. The device is classified under product code JTO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the API GERM TUBE?

API GERM TUBE is a medical device that received FDA 510(k) clearance on 1981-10-26. The listed applicant is Analytab Products, Inc.. The 510(k) number is K812862.

When did API GERM TUBE receive FDA 510(k) clearance?

API GERM TUBE received FDA 510(k) clearance on 1981-10-26, under 510(k) number K812862.

Who is the listed applicant for API GERM TUBE?

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 API GERM TUBE?

The FDA product code for API GERM TUBE is JTO.

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-MICK861408MODIFIED UNISCEPT KB LABELING AMENDMENTK812877PENASE

Related Devices (Code: JTO)

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.

K050352IN-VITRO DIAGNOSTIC VAGINITIS TEST KITAmeritek Research, LLCK970832PYR SWABRemel, Inc.K970834GRAM SWABRemel, Inc.K970833INDOLE SWABRemel, Inc.K970009LYFO(TM) DIFFERENTIAL DISK-BACITRACINMicrobiologics, Inc.K962966IDS RAPID CB PLUS SYSTEMInnovative Diagnostic Systems, Inc.

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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