FDA 510(k)

BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG

K-Number: K070921 · 2007-06-29

Decision Date2007-06-29

Product CodeJHI

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG is the device name listed in this FDA 510(k) record. The listed applicant is Applied Dna Technologies, Inc.. It received FDA 510(k) clearance on 2007-06-29 under 510(k) number K070921. 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 BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG?

BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG is a medical device that received FDA 510(k) clearance on 2007-06-29. The listed applicant is Applied Dna Technologies, Inc.. The 510(k) number is K070921.

When did BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG receive FDA 510(k) clearance?

BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG received FDA 510(k) clearance on 2007-06-29, under 510(k) number K070921.

Who is the listed applicant for BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG?

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

What is the FDA product code for BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG?

The FDA product code for BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG is JHI.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Applied Dna Technologies, Inc. as applicant

K080467BIONEXA SINGLE AND MULTI-STRIP CASSETTE/DIPSTICK DOA SCREEN PANELS ( AMP, BAR, BZO, COC, MET, MTD, MOR, PCP, TCA, THC,K071030BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC AND 02-HCGC K061005ACCUSTEP DOA SINGLE AND MULTI-STRIP SCREEN PANELS

Related Devices (Code: JHI)

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.