Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
JHJ — Predicate Candidate Screening
96 FDA 510(k) clearances under this product code; the 50 most recent screened below.
48 daysmedian FDA review time
96 days90th percentile
96clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972606 | PREGNACOL PREGNANCY TEST | Immunostics Inc., | 1997-08-29 | 49 | 0 |
| K921968 | IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST | Tech-Co, Inc. | 1996-06-28 | 1523 | 0 |
| K935863 | SAS(TM) DIRECT MONOCLONAL HCG | Sa Scientific, Inc. | 1994-02-24 | 83 | 0 |
| K926112 | ACCUTEX BETA-HCG TEST | J.S. Medical Assoc. | 1993-07-28 | 237 | 0 |
| K930609 | SAS(TM) MONOCLONAL HCG-SLIDE | Sa Scientific, Inc. | 1993-03-29 | 52 | 0 |
| K920716 | DIRECT PREGNANCY TEST | Tech-Co, Inc. | 1992-03-24 | 35 | 0 |
| K910946 | CLEARVIEW HCG | Unipath , Ltd. | 1991-04-01 | 26 | 0 |
| K881435 | PREGNOSPIA II | Organon Teknika Corp. | 1988-05-27 | 52 | 0 |
| K880163 | PREGNANCY (HCG) CARD & LIQUID TEST | Ampcor, Inc. | 1988-05-17 | 125 | 0 |
| K880478 | PREGNANCY BETA-HCG CARD & LIQUID TEST | Ampcor, Inc. | 1988-04-28 | 84 | 0 |
| K880328 | HCG-NOSTICK | Organon Teknika Corp. | 1988-03-15 | 49 | 0 |
| K875262 | V-TREND BETA-HCG DRY-SPOT TEST | Texas Immunology, Inc. | 1988-02-02 | 42 | 0 |
| K874638 | V-TREND BETA-HCG TEST | Texas Immunology, Inc. | 1988-01-21 | 70 | 0 |
| K871294 | ACU-PREG-AL SLIDE TEST | Papibris Scientific, Inc. | 1987-05-12 | 42 | 0 |
| K863741 | IMMUNO-CEPT D (BETA-MONOCLONAL) | Immunostics Co., Inc. | 1986-11-13 | 51 | 0 |
| K861211 | MONO ACU-SLIDE TEST | Cal-Tech Diagnostics, Inc. | 1986-11-05 | 219 | 0 |
| K863198 | PREGNASLIDE | Armkel, LLC | 1986-09-29 | 41 | 0 |
| K861703 | LEECO CONCEP-7-BHCG (EIA) II (MODIFIED) | Leeco Diagnostics, Inc. | 1986-07-29 | 85 | 0 |
| K862044 | DELFIA (TM) HCG KIT | Lkb Instruments, Inc. | 1986-07-11 | 44 | 0 |
| K861212 | DIRECT ACU-SLIDE TEST | Cal-Tech Diagnostics, Inc. | 1986-07-07 | 98 | 0 |
| K862083 | HYGEIA SCIENCES URINE HCG FLOW THORUGH ASSAY | Hygeia Sciences | 1986-07-02 | 30 | 0 |
| K860945 | DIRECTACLONE CG SLIDE PREGNANCY TEST | Pacific Biotech, Inc. | 1986-05-02 | 51 | 0 |
| K854670 | TERUMO SENSIBEAD EIG HCG KIT | Terumo Medical Corp. | 1986-02-13 | 84 | 0 |
| K853247 | ACU-SLIDE-TEST | Cal-Tech Diagnostics, Inc. | 1985-09-04 | 34 | 0 |
| K852286 | DIRRECT AGGLUTINATION(DAG) PREGNANCY TEST | Sero-Immuno Diagnostics, Inc. | 1985-07-09 | 41 | 0 |
| K852066 | PREGNANCY CARD TEST | Em Diagnostic Systems, Inc. | 1985-06-25 | 46 | 0 |
| K850604 | PRECO PREGNANCY RAPID CARD TEST, HEM #2028 | Preco, Inc. | 1985-04-08 | 52 | 0 |
| K844346 | FISHER DIAGNOSTICS PREGNACLONE SLIDE PREGNANCY TES | Fisher Diagnostics | 1985-03-04 | 115 | 0 |
| K844914 | ABBOTT PREGNA-PLUS HUMAN CHORIONIC GONADOTROPIN EN | Abbott Laboratories | 1985-02-12 | 56 | 0 |
| K844347 | FISHER DIAG. PREGNACLONE TUBE PREGNANCY TEST KIT | Fisher Diagnostics | 1985-01-23 | 75 | 0 |
| K842544 | STANBIO QUICK-TELL MONOCLONAL INDIRECT | Stanbio Laboratory | 1984-09-21 | 81 | 0 |
| K842314 | DUOCLON COLOR-CEPT | Organon, Inc. | 1984-08-24 | 73 | 0 |
| K842181 | BETA-HCG HEMAGGLUTINATION TEST | Sero-Immuno Diagnostics, Inc. | 1984-08-22 | 82 | 0 |
| K842110 | SLIDE PREGNANCY TEST | Immunostics Co., Inc. | 1984-07-12 | 44 | 0 |
| K841853 | PREG-BETA ONE HOUR TUBE TEST | Intl. Diagnostic, Inc. | 1984-06-22 | 50 | 0 |
| K840833 | PREG BETA BLUS SLIDE | Intl. Diagnostic, Inc. | 1984-05-30 | 96 | 0 |
| K840738 | PLUS URINE HCG ASSAY | Monoclonal Antibodies, Inc. | 1984-04-19 | 58 | 0 |
| K840650 | B-NEOCEPT 30 | Organon, Inc. | 1984-04-04 | 49 | 0 |
| K834346 | BHCG-CHECK | Diagnostic Technology, Inc. | 1984-02-04 | 54 | 0 |
| K832867 | FERTITUBE PREGNANCY TEST #1120 | Stanbio Laboratory | 1984-02-03 | 163 | 0 |
| K833137 | ORTHO B-HCG SLIDE TEST FOR PREGNANCY | Ortho Diagnostic Systems, Inc. | 1984-01-18 | 126 | 0 |
| K833504 | PREGNASTICK URINE HCG KIT | Monoclonal Antibodies, Inc. | 1984-01-09 | 96 | 0 |
| K833156 | QUIDEL HCG ENZYME IMMUNOASSAY KIT | Quidel Corp. | 1983-11-25 | 70 | 0 |
| K832918 | PREGNA-TEC | Medilab Corp. | 1983-11-03 | 70 | 0 |
| K832879 | B-SLIDE PREGNATE PREGNANCY TEST KIT | Fisher Scientific Co., LLC | 1983-10-28 | 63 | 0 |
| K832640 | QUICK-TELL INDIRECT PREGNANCY TEST | Stanbio Laboratory | 1983-10-04 | 61 | 0 |
| K832599 | EARLY IN HOME PREGNANCY TEST | Warner-Lambert Co. | 1983-09-20 | 49 | 0 |
| K832557 | FERTITELL DIRECT PREGNANCY TEST #1100 | Stanbio Laboratory | 1983-09-12 | 42 | 0 |
| K832527 | PREGNA-TEC | Medilab Corp. | 1983-09-12 | 45 | 0 |
| K832473 | GAMMA SLIDE TEST FOR PREGNANCY | Gamma Biologicals, Inc. | 1983-08-16 | 21 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda