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)

BETA-TEC

K-Number: K781794 · 1978-12-29

ApplicantWampole Laboratories
Decision Date1978-12-29
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BETA-TEC is the device name listed in this FDA 510(k) record. The listed applicant is Wampole Laboratories. It received FDA 510(k) clearance on 1978-12-29 under 510(k) number K781794. 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 BETA-TEC?

BETA-TEC is a medical device that received FDA 510(k) clearance on 1978-12-29. The listed applicant is Wampole Laboratories. The 510(k) number is K781794.

When did BETA-TEC receive FDA 510(k) clearance?

BETA-TEC received FDA 510(k) clearance on 1978-12-29, under 510(k) number K781794.

Who is the listed applicant for BETA-TEC?

The FDA 510(k) record lists Wampole Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BETA-TEC?

The FDA product code for BETA-TEC is JHI.

Other records listing Wampole Laboratories 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.

K965129BORRELIA BURGDORFERI IGM ELISA TEST SYSTEMK965131BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEMK911444RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEMK882896ONE-STEP HCGK883004MONO-PLUS(TM)K875101VIROGEN CMV ANTIBODY TEST

View all 12 devices →

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.

↑