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FDA 510(k)

INDOLE SPOT TEST KIT 270-25

K-Number: K843316 · 1984-09-11

ApplicantApplied Polytechnology, Inc.
Decision Date1984-09-11
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

INDOLE SPOT TEST KIT 270-25 is the device name listed in this FDA 510(k) record. The listed applicant is Applied Polytechnology, Inc.. It received FDA 510(k) clearance on 1984-09-11 under 510(k) number K843316. 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 INDOLE SPOT TEST KIT 270-25?

INDOLE SPOT TEST KIT 270-25 is a medical device that received FDA 510(k) clearance on 1984-09-11. The listed applicant is Applied Polytechnology, Inc.. The 510(k) number is K843316.

When did INDOLE SPOT TEST KIT 270-25 receive FDA 510(k) clearance?

INDOLE SPOT TEST KIT 270-25 received FDA 510(k) clearance on 1984-09-11, under 510(k) number K843316.

Who is the listed applicant for INDOLE SPOT TEST KIT 270-25?

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

What is the FDA product code for INDOLE SPOT TEST KIT 270-25?

The FDA product code for INDOLE SPOT TEST KIT 270-25 is JTO.

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Other records listing Applied Polytechnology, 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.

K860483FILTRA-CHECK-UTIK843834BACTERIURIA DETECT. DEVICE APTEK IIK843833BACTERIURIA DETECT DEVICE, MULTI SAMPLERK843359URINE TRANSPORT KITK840257RAPID IMMUNO-ASSAY SYSK834264REVERSE-FLOW SYSTEM

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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

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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