FDA Product Code
FDA Product Code LCX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1155
510(k) Clearances — 226 records · page 3 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K861168 | CLEARBLUE PREGNANCY TESTING KIT | Unipath , Ltd. | 1986-04-24 | Traditional | PDF ↗ |
| K860451 | MUREX (TM), SUDS (TM), HCG ASSAY | Murex Corp. | 1986-04-21 | Traditional | PDF ↗ |
| K860090 | ANSWER PLUS AT HOME PREGNANCY TEST | Armkel, LLC | 1986-04-11 | Traditional | PDF ↗ |
| K853269 | PREGNA/TEST | Modern Diagnostics, Inc. | 1985-10-03 | Traditional | PDF ↗ |
| K852274 | ANSWER | Armkel, LLC | 1985-06-28 | Traditional | PDF ↗ |
| K850079 | NOW HOME PREGN. TEST KIT ENZYME IMMUNOASSAY HCG | Bioclinical Systems, Inc. | 1985-03-05 | Traditional | PDF ↗ |
| K844281 | PTK HEALTHCHECK PREGNANCY TEST KIT | Healthcheck Corp. | 1984-12-10 | Traditional | PDF ↗ |
| K834474 | H.P.T. HOME PREG. TEST KIT & A.P.T. | Biomedical Research & Development Laboratories, Inc. | 1984-09-28 | Traditional | PDF ↗ |
| K843238 | ANSWER ONE-DAY | Armkel, LLC | 1984-09-14 | Traditional | PDF ↗ |
| K842265 | ORTHO BRAND HOME PREGNANCY TEST | Advanced Care Products | 1984-07-17 | Traditional | PDF ↗ |
| K841415 | BETA STICK, PREGNANCY TEST | Quidel Corp. | 1984-07-11 | Traditional | PDF ↗ |
| K841595 | HEALTHCHECK HOME PREGNANCY TEST KIT | Timex Medical Products Corp. | 1984-05-31 | Traditional | PDF ↗ |
| K841602 | ACCURATE BETA 30 PREGNANCY TEST KIT | Organon, Inc. | 1984-05-22 | Traditional | PDF ↗ |
| K834270 | ORTHO ENZYME IMMUNOASSAY HOME PREG.TEST | Advanced Care Products | 1984-05-14 | Traditional | PDF ↗ |
| K840602 | VERIFY PREGNANCY TEST KIT | O.T.C. Diagnostics, Inc. | 1984-03-19 | Traditional | PDF ↗ |
| K832905 | QUALITATIVE ENZYME IMMUNOASSAY-DETECT | Btc Diagnostics, Inc. | 1984-02-03 | Traditional | PDF ↗ |
| K832593 | HOSPITAL LAB IN-HOME EARLY PREG TEST | Aicl-Pack, Inc. | 1984-01-11 | Traditional | PDF ↗ |
| K833466 | EARLY PREGNANCY DETECTION TEST KIT | Quidel Corp. | 1983-11-25 | Traditional | PDF ↗ |
| K831051 | HOME PREGNANCY TEST KIT HPK #1 | Quidel Corp. | 1983-05-18 | Traditional | PDF ↗ |
| K831108 | HOME PREGNANCY TEST KIT | Quidel Corp. | 1983-05-18 | Traditional | PDF ↗ |
| K823109 | GENERIC PREGNANCY TEST | Diagnostic Specialties | 1982-11-10 | Traditional | PDF ↗ |
| K822449 | TPK 1980/1 | Plantex USA, Inc. | 1982-10-27 | Traditional | PDF ↗ |
| K813272 | A-1 IN-HOME PREGNANCY TEST | C.F. Medical, Inc. | 1981-12-17 | Traditional | PDF ↗ |
| K780321 | PREGNANCY TEST KIT, OVER-THE-COUNTER | Intl. Diagnostic, Inc. | 1978-04-04 | Traditional | PDF ↗ |
| K780240 | PREDICTOR | Organon, Inc. | 1978-02-27 | Traditional | PDF ↗ |
| K772359 | PREGNANCY TEST KIT, ANSWER | Diagnostic Testing, Inc. | 1978-01-05 | Traditional | PDF ↗ |
Product code LCX · Class II · Clinical Chemistry. Data: openFDA.