Fluorescent Microbead Alignment Standards TM
FDA 510(k) K851450 · Flow Cytometry Standards Corp.
510(k) numberK851450
Submission
- Device name
- Fluorescent Microbead Alignment Standards TM
- Applicant
- Flow Cytometry Standards Corp.
Research Triangle Park, NC, US - Received
- April 11, 1985
- Decision date
- September 16, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JIW – Calibrator, Surrogate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JIW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K973055 | Wako CH50 Linearity SetJIW · Traditional | Wako Chemicals USA, Inc. | 09/25/1997SE |
| K970396 | Human Chorionic Gonadotropin CalibratorJIW · Traditional | Dade Chemistry Systems, Inc. | 02/20/1997SE |
| K910255 | Flow Cytometry Fitc/Pe Compensation KitJIW · Traditional | Sigma Diagnostics, Inc. | 04/03/1991SE |
| K902575 | Sopheia 1000 (S1CAL) & Sopheia 2000 (S2CAL)JIW · Traditional | Diagnostic Products Corp. | 10/04/1990SE |
| K902294 | Accuscan Microbead StandardsJIW · Traditional | Sigma Chemical Co. | 07/03/1990SE |
| K892213 | Acs Colloid Osmotic Pressure CalibratorJIW · Traditional | Analytical Control Systems, Inc. | 06/21/1989SE |
| K883389 | Raichem(Tm) Bilirubin Conjugate StandardJIW · Traditional | Reagents Applications, Inc. | 12/14/1988SE |
| K882220 | Calibration KitJIW · Traditional | King Diagnostics, Inc. | 08/02/1988SE |
| K880654 | Amresco Liquizyme Glucose/Bun Standard 0124, 0200JIW · Traditional | American Research Products Co. | 06/07/1988SE |
| K880610 | Unimeter Calibration KitJIW · Traditional | Boehringer Mannheim Corp. | 03/24/1988SE |
Questions and answers
When was Fluorescent Microbead Alignment Standards TM cleared by the FDA?
Fluorescent Microbead Alignment Standards TM (K851450) received a 510(k) decision of Substantially Equivalent on September 16, 1985, 158 days after the submission was received.
What is the product code of K851450?
The FDA product code is JIW – Calibrator, Surrogate, a Class II (moderate risk) device regulated under 21 CFR 862.1150.