Coulter Clone Quick Stain Whole Blood Lyse-Ii
FDA 510(k) K883836 · Coulter Immunology
510(k) numberK883836
Submission
- Device name
- Coulter Clone Quick Stain Whole Blood Lyse-Ii
- Applicant
- Coulter Immunology
Hialeah, FL, US - Received
- September 12, 1988
- Decision date
- November 30, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GGK – Products, Red-Cell Lysing Products
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.8540
- Specialty
- Hematology
Other 510(k)s with product code GGK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K883991 | KVM Hemoglobin Lysing ReagentGGK · Traditional | Kvm Technologies, Inc. | 10/12/1988SE |
| K874054 | Fisher Diagnostics Hematall III Las ReagentGGK · Traditional | Fisher Scientific Co., LLC | 10/20/1987SE |
| K873348 | Cell-Dyn Diff Screen, Auto. & Semi Auto. Lytic Ag.GGK · Traditional | Abbott Diagnostics | 09/09/1987SE |
| K863114 | PiastrinitGGK · Traditional | J. D. Assoc. | 11/06/1986SE |
| K863503 | HemolyseGGK · Traditional | Reagent Laboratory, Inc. | 10/03/1986SE |
| K850944 | Nsi Lysing-D Reagent -4000 MLGGK · Traditional | Nobel Scientific Industries, Inc. | 03/29/1985SE |
| K850097 | Laser-LyseGGK · Traditional | Hematology Marketing Assoc. | 03/29/1985SE |
| K842938 | Acetic Acid 1% V/VGGK · Traditional | E K Ind., Inc. | 09/14/1984SE |
| K842937 | Acetic Acid 2% V/VGGK · Traditional | E K Ind., Inc. | 09/12/1984SE |
| K842936 | Acetic Acid, 3% V/VGGK · Traditional | E K Ind., Inc. | 09/12/1984SE |
More from E K Ind., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K922745 | Cyto-Stat/Coulter Clone CD3(IGG1)-FITC/T4-RD1GKZ · Traditional | 02/05/1993SE |
| K922744 | Cyto-Stat/Coulter Clone CD 3(IGG1)-FITC/T8-RD1GKZ · Traditional | 02/05/1993SE |
| K910473 | Cyto-Stat(R)/Coulter Clone(R) T11-RD1/B4-FITCGKZ · Traditional | 10/31/1991SE |
| K911793 | CoultercloneGKZ · Traditional | 07/09/1991SE |
| K893853 | Coulter Clone T8 Monoclonal AntibodyGKZ · Traditional | 03/02/1990SE |
| K893852 | Coulter Clone T4 Monoclonal AntibodyGKZ · Traditional | 03/02/1990SE |
| K894179 | Coulter Clone(R) MY4 Monoclonal AntibodyGKZ · Traditional | 02/12/1990SE |
| K895917 | Cyto-Stat/Coulter Clone T4-RD1/T8-FITC Mono AntiGKZ · Traditional | 12/29/1989SE |
| K884605 | Coulter Clone MO2GKZ · Traditional | 08/15/1989SE |
| K893419 | Coulter Clone Gam-Fitc Poly Anti (Igg & Igm)DEW · Traditional | 08/03/1989SE |
Questions and answers
When was Coulter Clone Quick Stain Whole Blood Lyse-Ii cleared by the FDA?
Coulter Clone Quick Stain Whole Blood Lyse-Ii (K883836) received a 510(k) decision of Substantially Equivalent on November 30, 1988, 79 days after the submission was received.
What is the product code of K883836?
The FDA product code is GGK – Products, Red-Cell Lysing Products, a Class I (low risk) device regulated under 21 CFR 864.8540.