RDW and MPV Indices on Hemat 12
FDA 510(k) K900684 · Texas Intl. Laboratories, Inc.
510(k) numberK900684
Submission
- Device name
- RDW and MPV Indices on Hemat 12
- Applicant
- Texas Intl. Laboratories, Inc.
Needham, MA, US - Received
- February 12, 1990
- Decision date
- April 16, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GKZ – Counter, Differential Cell
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5220
- Specialty
- Hematology
Other 510(k)s with product code GKZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253212 | XR-Series (XR-10, XR-20) Automated Hematology AnalyzersGKZ · Traditional | Sysmex America, Inc. | 05/27/2026SE |
| K243348 | Athelas HomeGKZ · Traditional | Athelas, Inc. | 02/06/2026SE |
| K251249 | Tru Hematology TestGKZ · Traditional | Truvian Sciences, Inc. | 01/16/2026SE |
| K251371 | Sysmex XR-Series (XR-20) Automated Hematology AnalyzerGKZ · Traditional | Sysmex America, Inc. | 06/25/2025SE |
| K250943 | Sysmex XR-Series (XR-10) Automated Hematology AnalyzerGKZ · Traditional | Sysmex America, Inc. | 06/25/2025SE |
| K243283 | Alinity h-series SystemGKZ · Traditional | Abbott Laboratories | 02/20/2025SE |
| K240402 | Cito CBC SystemGKZ · Dual Track | Cytochip, Inc. | 02/03/2025SE |
| K240252 | UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II…GKZ · Traditional | Beckman Coulter, Inc. | 07/05/2024SE |
| K232946 | Yumizen H2500GKZ · Traditional | Horiba Abx SAS | 05/21/2024SE |
| K240636 | HemoScreen Hematology AnalyzerGKZ · Abbreviated | Pixcell Medical Technologies | 05/02/2024SE |
More from Pixcell Medical Technologies
| 510(k) | Device | Decision |
|---|---|---|
| K953643 | Hematil 18 (H-18)GKZ · Traditional | 03/22/1996SE |
| K904031 | Chema Chol Cholesterol SystemCHH · Traditional | 03/11/1991SE |
| K900685 | Clot 2 Semiautomatic Coagulation AnalyzerKQG · Traditional | 04/16/1990SE |
| K884006 | Hemat 12GKZ · Traditional | 12/05/1988SE |
| K883177 | H 10 or Hematil 10 Blood Cell & Platelet CounterGKZ · Traditional | 11/30/1988SE |
| K853722 | PLT-4 Platelet AnalyzerGKL · Traditional | 01/17/1986SE |
| K832886 | Flame Photometer T281-T282-T283JJO · Traditional | 12/08/1983SE |
| K832890 | Hemacomp 7 or Hematil 7GKL · Traditional | 10/19/1983SE |
| K831649 | Thermomixer S213-PHOTOANALYZER S263JJE · Traditional | 08/24/1983SE |
Questions and answers
When was RDW and MPV Indices on Hemat 12 cleared by the FDA?
RDW and MPV Indices on Hemat 12 (K900684) received a 510(k) decision of Substantially Equivalent on April 16, 1990, 63 days after the submission was received.
What is the product code of K900684?
The FDA product code is GKZ – Counter, Differential Cell, a Class II (moderate risk) device regulated under 21 CFR 864.5220.