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FDA 510(k)

PRO-STEP PT HCG

K-Number: K925303 · 1993-06-15

ApplicantDisease Detection International, Inc.
Decision Date1993-06-15
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PRO-STEP PT HCG is the device name listed in this FDA 510(k) record. The listed applicant is Disease Detection International, Inc.. It received FDA 510(k) clearance on 1993-06-15 under 510(k) number K925303. 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 PRO-STEP PT HCG?

PRO-STEP PT HCG is a medical device that received FDA 510(k) clearance on 1993-06-15. The listed applicant is Disease Detection International, Inc.. The 510(k) number is K925303.

When did PRO-STEP PT HCG receive FDA 510(k) clearance?

PRO-STEP PT HCG received FDA 510(k) clearance on 1993-06-15, under 510(k) number K925303.

Who is the listed applicant for PRO-STEP PT HCG?

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

What is the FDA product code for PRO-STEP PT HCG?

The FDA product code for PRO-STEP PT HCG is JHI.

Other records listing Disease Detection International, 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.

K943252PRO-STEP LH OVULATION PREDICTION TESTK925125PRO-STEP HCGK911826IMMUNOCARD HCG ONE STEP (I-S) TEST KITK902571MODIFICATION OF SEROCARD RUBELLA IGG TESTK903070SEROCARD HSV IGG ANTIBODY TEST KITK895912IMMUNOCARD HCG II-S TEST KIT

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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

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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