Reagent, Lysing and Hemoglobin
FDA 510(k) K782098 · Dade, Baxter Travenol Diagnostics, Inc.
510(k) numberK782098
Submission
- Device name
- Reagent, Lysing and Hemoglobin
- Applicant
- Dade, Baxter Travenol Diagnostics, Inc.
Mchenry, IL, US - Received
- December 18, 1978
- Decision date
- January 17, 1979
- 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 |
|---|---|---|---|
| K883836 | Coulter Clone Quick Stain Whole Blood Lyse-IiGGK · Traditional | Coulter Immunology | 11/30/1988SE |
| 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 |
More from E K Ind., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K800296 | Whole Blood Gas Control, Levels 1,2,&3GGM · Traditional | 03/05/1980SE |
| K792606 | Whole Blood Platelet Control Normal,JPK · Traditional | 02/13/1980SE |
| K792723 | Blood Fluid FiltersJKA · Traditional | 01/21/1980SE |
| K792607 | T3 Uptake (T3U) ReagentsKHQ · Traditional | 01/16/1980SE |
| K792443 | TSH RadioimmunoassayJLW · Traditional | 12/27/1979SE |
| K792442 | Ferritin RadioimmunoassayDBF · Traditional | 12/18/1979SE |
| K791922 | Harleco Brand Clinicard Lipase Test SetCET · Traditional | 11/27/1979SE |
| K792183 | Dade High Density Lipoprotein CholesteroLBS · Traditional | 11/13/1979SE |
| K790776 | Dade Low Ionic Strength Soluition (Liss)KSG · Traditional | 05/23/1979SE |
| K790767 | Immu-Tek Automatic CentrifugeKSN · Traditional | 05/23/1979SE |
Questions and answers
When was Reagent, Lysing and Hemoglobin cleared by the FDA?
Reagent, Lysing and Hemoglobin (K782098) received a 510(k) decision of Substantially Equivalent on January 17, 1979, 30 days after the submission was received.
What is the product code of K782098?
The FDA product code is GGK – Products, Red-Cell Lysing Products, a Class I (low risk) device regulated under 21 CFR 864.8540.