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FDA 510(k)

BACTERIURIA DETECT. DEVICE APTEK II

K-Number: K843834 · 1984-11-29

ApplicantApplied Polytechnology, Inc.
Decision Date1984-11-29
Product CodeJXA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BACTERIURIA DETECT. DEVICE APTEK II 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 1984-11-29 under 510(k) number K843834. The device is classified under product code JXA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BACTERIURIA DETECT. DEVICE APTEK II?

BACTERIURIA DETECT. DEVICE APTEK II is a medical device that received FDA 510(k) clearance on 1984-11-29. The listed applicant is Applied Polytechnology, Inc.. The 510(k) number is K843834.

When did BACTERIURIA DETECT. DEVICE APTEK II receive FDA 510(k) clearance?

BACTERIURIA DETECT. DEVICE APTEK II received FDA 510(k) clearance on 1984-11-29, under 510(k) number K843834.

Who is the listed applicant for BACTERIURIA DETECT. DEVICE APTEK II?

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 BACTERIURIA DETECT. DEVICE APTEK II?

The FDA product code for BACTERIURIA DETECT. DEVICE APTEK II is JXA.

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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-UTIK843833BACTERIURIA DETECT DEVICE, MULTI SAMPLERK843359URINE TRANSPORT KITK843316INDOLE SPOT TEST KIT 270-25K840257RAPID IMMUNO-ASSAY SYSK834264REVERSE-FLOW SYSTEM

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Related Devices (Code: JXA)

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.

K011043OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)OsmetechK981084URISCREENDiatech Diagnostics,Inc.K972676URINE SCREENING DEVICECombact Diagnostic Systems , Ltd.K952246TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KITTri-Tech, Inc.K950257MULTIPLE (IZON DBS & URINE COLLECTION KIT)Izon Business Products, Inc.K950221MULTIPLE (IZON BLOOD & URINE COLLECTION KIT)Izon Business Products, 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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