Solid State Continuous Flow Control Model W/K101
FDA 510(k) K861460 · Widran Urological Group, Ltd.
510(k) numberK861460
Submission
- Device name
- Solid State Continuous Flow Control Model W/K101
- Applicant
- Widran Urological Group, Ltd.
Chicago, IL, US - Received
- April 18, 1986
- Decision date
- May 2, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LJK – Antisera, If, Toxoplasma Gondii
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3780
- Specialty
- Microbiology
Other 510(k)s with product code LJK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974261 | Accurun 135 Toxoplasma Igg Positive ControlLJK · Traditional | Boston Biomedica, Inc. | 12/11/1997SE |
| K911771 | Ard(Tm) Antimicrobial Removal DeviceLJK · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 07/01/1991SE |
| K861122 | The Golden Quad Test (Toxo)LJK · Traditional | Microbiological Research Corp. | 02/02/1987SE |
| K832069 | Toxo Ipa Kit Ian Indirect FluorescentLJK · Traditional | Bionetic Laboratory Products | 09/26/1983SE |
| K822605 | Toxoplasma Gondii Antibody IggLJK · Traditional | Immulok, Inc. | 10/27/1982SE |
More from Immulok, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K822743 | Solid State Continuous Flow ControlLJH · Traditional | 09/24/1982SE |
Questions and answers
When was Solid State Continuous Flow Control Model W/K101 cleared by the FDA?
Solid State Continuous Flow Control Model W/K101 (K861460) received a 510(k) decision of Substantially Equivalent on May 2, 1986, 14 days after the submission was received.
What is the product code of K861460?
The FDA product code is LJK – Antisera, If, Toxoplasma Gondii, a Class II (moderate risk) device regulated under 21 CFR 866.3780.