Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER

K-Number: K122907 · 2013-03-14

ApplicantPolymed Therapeutics, Inc.
Decision Date2013-03-14
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER 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 2013-03-14 under 510(k) number K122907. The device is classified under product code LCX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER?

FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER is a medical device that received FDA 510(k) clearance on 2013-03-14. The listed applicant is Polymed Therapeutics, Inc.. The 510(k) number is K122907.

When did FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER receive FDA 510(k) clearance?

FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER received FDA 510(k) clearance on 2013-03-14, under 510(k) number K122907.

Who is the listed applicant for FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER?

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 AT-HOME PREGNANCY, HCG, OVER THE COUNTER?

The FDA product code for FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER is LCX.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 DEVICEK112101FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS

Related Devices (Code: LCX)

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.

K251040MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy TestGuangzhou Decheng Biotechnology Co., Ltd.K251053Shinetell PlusTM Digital Early Pregnancy TestHangzhou AllTest Biotech Co., Ltd.K250117FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteAssure Tech., LLCK242135Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test MidstreamNanjing Synthgene Medical Technology Co., Ltd.K243573FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test MidstreamAssure Tech., LLCK241394iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test StripAndon Health Co, Ltd.

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.

↑