Atlas FDA

HCG RADIOIMMUNOASSAY KIT (125I)

FDA 510(k) clearance K811421 · decided 1981-07-10

Clearance details

K-number
K811421
Device name
HCG RADIOIMMUNOASSAY KIT (125I)
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
Decision
Substantially Equivalent
Date received
1981-05-20
Decision date
1981-07-10
Days to decision
51 days
Clearance type
Traditional
Product code
JHI
Device class
2
Regulation number
862.1155
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Walker, MI, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Innovita HCG Pregnancy Rapid Combo Test (K241919)Innovita (Tangshan) Biological Technology Co., Ltd.2024-08-02
Alltest Pregnancy Rapid Combo Test Cassette (K203272)Hangzhou AllTest Biotech Co., Ltd.2022-01-31
Atellica IM Total hCG (ThCG) (K172322)Siemens Healthcare Diagnostics, Inc.2018-03-29
TrueDX 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) (K172257)True Diagnostics, Inc.2017-12-22
Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip (K152768)Assure Tech. Co., Ltd.2016-02-24
WUNDER PREGNANCY TEST (K130456)James Nguyen2014-04-08
FASTEP S10 HCG SERUM/URINE COMBO TEST (K132834)Polymed Therapeutics, Inc.2014-01-09
SOFIA(R) HCG FIA (K131166)Quidel Corp.2013-08-02
CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST (K123844)Chemtron Biotech, Inc.2013-05-30
FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS (K112101)Polymed Therapeutics, Inc.2012-07-17
HOME PREGNANCY TEST (K112315)Newscen Coast Bio-Pharmaceutical Co., Ltd.2012-04-23
RAPIDVUE HCG TEST (K102175)Quidel Corporation2010-08-25

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
OXYCELL (N5798/S007)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-07-24
OXYCEL OXIDIZED (N5798/S005)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-02-08
OXYCELL (N5798/S006)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-02-08
MINI BALLOON (P780011/S012)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-10-30
MINI BALLOON (P780011/S011)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-10-18
MINI BALLOON (P780011/S010)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-01-29
MINI BALLOON (P780011/S007)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-01-23
BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC (P800030/S006)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-11-05