JFH — Acid Phosphatase (Prostatic), Tartrate Inhibited Class II
FDA product code JFH covers "Acid Phosphatase (Prostatic), Tartrate Inhibited", a Class II medical device regulated under 21 CFR 862.1020. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JFH
- Device Class
- Class II
- Regulation Number
- 862.1020
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K000257 | diagnostic products | IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6 | February 23, 2000 |
| K981573 | united biotech | UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE | September 15, 1998 |
| K964756 | wano-tech | PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT | April 23, 1997 |
| K931701 | diagnostic products | IMMULITE PAP | January 27, 1994 |
| K925377 | abbott laboratories | IMX PAP | January 13, 1993 |
| K921745 | hybritech | HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO | July 30, 1992 |
| K902937 | diagnostic products | MILENIA PAP IRMA CATALOG #: MKPA1, X | September 21, 1990 |
| K901933 | diagnostic products | COAT-A-COUNT PAP IRMA, CATLOG# 1KPA1, 1KPA2 | June 28, 1990 |
| K895723 | diagnostic products | IRMA-COUNT(TM) PAP, (RKPA1, RKPA2) | October 31, 1989 |
| K893508 | baxter healthcare | PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI | August 4, 1989 |
| K884748 | technicon instruments | TECHNICON CHEM 1 SYSTEM ACID PHOS (PROSTATIC) | January 30, 1989 |
| K873903 | abbott laboratories | ABBOTT PAP-EIA | December 1, 1987 |
| K864945 | hybritech | TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAY | January 5, 1987 |
| K863832 | pointe scientific, inc | NAPHTHYL PHOSPHATE, ACID PHOSPHATASE | December 16, 1986 |
| K852845 | diagnostic products | PROSTATIC ACID PHOSPHATASE RADIOIMMUNOASSAY | September 4, 1985 |
| K851950 | hybritech | TANDEM E PAP | June 25, 1985 |
| K844679 | diagnostic systems laboratories | DSL PAP RIA -DSL#3100 | April 29, 1985 |
| K844968 | cetus | EPICHROME PAP | February 7, 1985 |
| K843230 | ventrex laboratories | VENTREZYME PAP KIT IMMUNOASSAY PROSTATIC | September 4, 1984 |
| K831670 | ortho diagnostic systems | ORTHO*PAP-IA ENDOGENOUS ENZYME IMMUNO | August 24, 1983 |