TECHNICON CHEM 1 SYSTEM ACID PHOS (PROSTATIC)
FDA 510(k) clearance K884748 · decided 1989-01-30
Clearance details
- K-number
- K884748
- Device name
- TECHNICON CHEM 1 SYSTEM ACID PHOS (PROSTATIC)
- Applicant
- Technicon Instruments Corp.
- Decision
- Substantially Equivalent
- Date received
- 1988-11-14
- Decision date
- 1989-01-30
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- JFH
- Device class
- 2
- Regulation number
- 862.1020
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Tarrytown, NY, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6 (K000257) | Diagnostic Products Corp. | 2000-02-23 |
| UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE (K981573) | United Biotech, Inc. | 1998-09-15 |
| PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT (K964756) | Wano-Tech Corp. | 1997-04-23 |
| IMMULITE PAP (K931701) | Diagnostic Products Corp. | 1994-01-27 |
| IMX PAP (K925377) | Abbott Laboratories | 1993-01-13 |
| HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO (K921745) | Hybritech, Inc. | 1992-07-30 |
| MILENIA PAP IRMA CATALOG #: MKPA1, X (K902937) | Diagnostic Products Corp. | 1990-09-21 |
| COAT-A-COUNT PAP IRMA, CATLOG# 1KPA1, 1KPA2 (K901933) | Diagnostic Products Corp. | 1990-06-28 |
| IRMA-COUNT(TM) PAP, (RKPA1, RKPA2) (K895723) | Diagnostic Products Corp. | 1989-10-31 |
| PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI (K893508) | Baxter Healthcare Corp | 1989-08-04 |
| ABBOTT PAP-EIA (K873903) | Abbott Laboratories | 1987-12-01 |
| TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAY (K864945) | Hybritech, Inc. | 1987-01-05 |
Recalls involving this device
No recalls on record reference this clearance.