Panels › Clinical Chemistry › Product code LCX · Class 2
Kit, Test, Pregnancy, Hcg, Over The Counter
Regulation 862.1155
0510(k)s in 12 months (226 all time)
2recalls in 12 months (25 all time)
16recalls that name a 510(k)
Top companies in LCX
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 24, 1986 | K861168 | CLEARBLUE PREGNANCY TESTING KIT Unipath , Ltd., GB | LCX |
| Apr 21, 1986 | K860451 | MUREX (TM), SUDS (TM), HCG ASSAY Murex Corp. | LCX |
| Apr 11, 1986 | K860090 | ANSWER PLUS AT HOME PREGNANCY TEST Armkel, LLC | LCX |
| Oct 3, 1985 | K853269 | PREGNA/TEST Modern Diagnostics, Inc. | LCX |
| Jun 28, 1985 | K852274 | ANSWER Armkel, LLC | LCX |
| Mar 5, 1985 | K850079 | NOW HOME PREGN. TEST KIT ENZYME IMMUNOASSAY HCG Bioclinical Systems, Inc. | LCX |
| Dec 10, 1984 | K844281 | PTK HEALTHCHECK PREGNANCY TEST KIT Healthcheck Corp. | LCX |
| Sep 28, 1984 | K834474 | H.P.T. HOME PREG. TEST KIT & A.P.T. Biomedical Research & Development Laboratories, Inc. | LCX |
| Sep 14, 1984 | K843238 | ANSWER ONE-DAY Armkel, LLC | LCX |
| Jul 17, 1984 | K842265 | ORTHO BRAND HOME PREGNANCY TEST Advanced Care Products | LCX |
| Jul 11, 1984 | K841415 | BETA STICK, PREGNANCY TEST Quidel Corp. | LCX |
| May 31, 1984 | K841595 | HEALTHCHECK HOME PREGNANCY TEST KIT Timex Medical Products Corp. | LCX |
| May 22, 1984 | K841602 | ACCURATE BETA 30 PREGNANCY TEST KIT Organon, Inc. | LCX |
| May 14, 1984 | K834270 | ORTHO ENZYME IMMUNOASSAY HOME PREG.TEST Advanced Care Products | LCX |
| Mar 19, 1984 | K840602 | VERIFY PREGNANCY TEST KIT O.T.C. Diagnostics, Inc. | LCX |
| Feb 3, 1984 | K832905 | QUALITATIVE ENZYME IMMUNOASSAY-DETECT Btc Diagnostics, Inc. | LCX |
| Jan 11, 1984 | K832593 | HOSPITAL LAB IN-HOME EARLY PREG TEST Aicl-Pack, Inc. | LCX |
| Nov 25, 1983 | K833466 | EARLY PREGNANCY DETECTION TEST KIT Quidel Corp. | LCX |
| May 18, 1983 | K831108 | HOME PREGNANCY TEST KIT Quidel Corp. | LCX |
| May 18, 1983 | K831051 | HOME PREGNANCY TEST KIT HPK #1 Quidel Corp. | LCX |
| Nov 10, 1982 | K823109 | GENERIC PREGNANCY TEST Diagnostic Specialties | LCX |
| Oct 27, 1982 | K822449 | TPK 1980/1 Plantex USA, Inc. | LCX |
| Dec 17, 1981 | K813272 | A-1 IN-HOME PREGNANCY TEST C.F. Medical, Inc. | LCX |
| Apr 4, 1978 | K780321 | PREGNANCY TEST KIT, OVER-THE-COUNTER Intl. Diagnostic, Inc. | LCX |
| Feb 27, 1978 | K780240 | PREDICTOR Organon, Inc. | LCX |
| Jan 5, 1978 | K772359 | PREGNANCY TEST KIT, ANSWER Diagnostic Testing, Inc. | LCX |
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