510(k) K883995
- Device
- X-ACT UREA/TDA
- Applicant
- PRO-LAB, INC.
- 510(k) number
- K883995
- Product code
- JSE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-10-12
- Date received
- 1988-09-20
- Regulation
- 866.2320
- Classification name
- Culture Media, Multiple Biochemical Test
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- KAY BAITZ
- Address
- 290 Larkin St. P.O. Box 1099 Buffalo NY US 14210 14210
FDA Registration Numbers#
- 3003750284
- 3005182159
- 2022807
- 3015715780
- 3005182157
- 1924669
- 1210083
- 3009547954
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JSE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K962265 | MLX MICROTITER PLATE LUMINOMETER | Dynatech Laboratories, Inc. | 1996-07-25 |
| K883996 | X-ACT LDC/IND | Pro-Lab, Inc. | 1988-10-12 |
| K880133 | MIL MEDIUM | Hardy Media | 1988-03-31 |
| K880116 | MRVP BROTH | Hardy Media | 1988-03-31 |
| K874537 | KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGAR | Lakewood Biochemical Co., Inc. | 1987-11-20 |
| K871096 | CYSTINE TRYPTIC AGAR W/O CARBOHYDRATES | bioMerieux, Inc. | 1987-04-03 |
| K864674 | MICRODILUTION IDENTIFICATION PANELS | American Micro Scan | 1987-01-05 |
| K862393 | BIOTIS LITMUS MILK | Otisville Biotech, Inc. | 1986-07-03 |
| K860412 | BIOTIS SIM MEDIUM | Otisville Biotech, Inc. | 1986-02-24 |
| K860413 | BIOTIS TSI | Otisville Biotech, Inc. | 1986-02-24 |
| K860414 | BIOTIS ORNITHINE INDOLE MOTILITY MEDIA | Otisville Biotech, Inc. | 1986-02-24 |
| K860415 | BIOTIS SIMMON CITRATE AGAR | Otisville Biotech, Inc. | 1986-02-24 |
| K860194 | AUSTIN ENTERIC SYSTEM | Austin Biological Laboratories | 1986-02-20 |
| K850982 | CTAPI - NEISSERA SCREEN | Analytical Products, Inc. | 1985-03-29 |
| K850734 | DIFFERENTIAL CULTURE MEDIUM | Roseville Medical Laboratoriesu | 1985-03-20 |
Legacy Summary#
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FDA Review#
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