X-Act Ldc/Ind
FDA 510(k) K883996 · Pro-Lab, Inc.
510(k) numberK883996
Submission
- Device name
- X-Act Ldc/Ind
- Applicant
- Pro-Lab, Inc.
Buffalo, NY, US - Received
- September 20, 1988
- Decision date
- October 12, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSE – Culture Media, Multiple Biochemical Test
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2320
- Specialty
- Microbiology
Other 510(k)s with product code JSE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K962265 | MLX Microtiter Plate LuminometerJSE · Traditional | Dynatech Laboratories, Inc. | 07/25/1996SE |
| K883995 | X-Act Urea/TdaJSE · Traditional | Pro-Lab, Inc. | 10/12/1988SE |
| K880133 | Mil MediumJSE · Traditional | Hardy Media | 03/31/1988SE |
| K880116 | MRVP BrothJSE · Traditional | Hardy Media | 03/31/1988SE |
| K874537 | Kligler Iron Agar and Triple Sugar Iron AgarJSE · Traditional | Lakewood Biochemical Co., Inc. | 11/20/1987SE |
| K871096 | Cystine Tryptic Agar W/O CarbohydratesJSE · Traditional | bioMerieux, Inc. | 04/03/1987SE |
| K864674 | Microdilution Identification PanelsJSE · Traditional | American Micro Scan | 01/05/1987SE |
| K862393 | Biotis Litmus MilkJSE · Traditional | Otisville Biotech, Inc. | 07/03/1986SE |
| K860415 | Biotis Simmon Citrate AgarJSE · Traditional | Otisville Biotech, Inc. | 02/24/1986SE |
| K860414 | Biotis Ornithine Indole Motility MediaJSE · Traditional | Otisville Biotech, Inc. | 02/24/1986SE |
More from Otisville Biotech, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K934383 | Prolex (Streptoccal Grouping Latex Kit)GTZ · Traditional | 01/27/1995SE |
| K914419 | Amniotest(Tm)HIO · Traditional | 09/01/1993SE |
| K921421 | Legionella Reagens for Direct Fluorescent AntibodyLHL · Traditional | 07/28/1992SE |
| K903714 | E. Coli 0157 Latex TestGNA · Traditional | 01/24/1991SE |
| K894221 | Rosco PyrrJTO · Traditional | 09/28/1989SE |
| K883995 | X-Act Urea/TdaJSE · Traditional | 10/12/1988SE |
| K871121 | Protect T.M.JTR · Traditional | 04/14/1987SE |
| K870117 | Neisseria/Branhamella Differential TestJSX · Traditional | 03/20/1987SE |
| K861142 | Master Kit BLRP · Traditional | 07/10/1986SESD |
| K861889 | D'Ala Rapid TestJTO · Traditional | 06/03/1986SE |
Questions and answers
When was X-Act Ldc/Ind cleared by the FDA?
X-Act Ldc/Ind (K883996) received a 510(k) decision of Substantially Equivalent on October 12, 1988, 22 days after the submission was received.
What is the product code of K883996?
The FDA product code is JSE – Culture Media, Multiple Biochemical Test, a Class I (low risk) device regulated under 21 CFR 866.2320.