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FDA 510(k)

FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS

K-Number: K112101 · 2012-07-17

ApplicantPolymed Therapeutics, Inc.
Decision Date2012-07-17
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS is the device name listed in this FDA 510(k) record. The listed applicant is Polymed Therapeutics, Inc.. It received FDA 510(k) clearance on 2012-07-17 under 510(k) number K112101. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS?

FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS is a medical device that received FDA 510(k) clearance on 2012-07-17. The listed applicant is Polymed Therapeutics, Inc.. The 510(k) number is K112101.

When did FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS receive FDA 510(k) clearance?

FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS received FDA 510(k) clearance on 2012-07-17, under 510(k) number K112101.

Who is the listed applicant for FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS?

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

What is the FDA product code for FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS?

The FDA product code for FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS is JHI.

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Other records listing Polymed Therapeutics, 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.

K121065POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICEK122907FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER

Related Devices (Code: JHI)

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.

K262299Instant-View® hCG Combo II Cassette TestAlfa Scientific Designs, Inc.K241919Innovita HCG Pregnancy Rapid Combo TestInnovita (Tangshan) Biological Technology Co., Ltd.K203272Alltest Pregnancy Rapid Combo Test CassetteHangzhou AllTest Biotech Co., Ltd.K172322Atellica IM Total hCG (ThCG)Siemens Healthcare Diagnostics, Inc.K172257TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)True Diagnostics, Inc.K152768Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test StripAssure Tech. Co., Ltd.

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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