Laser-Lyse
FDA 510(k) K850097 · Hematology Marketing Assoc.
510(k) numberK850097
Submission
- Device name
- Laser-Lyse
- Applicant
- Hematology Marketing Assoc.
Concord, CA, US - Received
- January 11, 1985
- Decision date
- March 29, 1985
- 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 |
| 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 |
|---|---|---|
| K851843 | Osmocel 3GIF · Traditional | 07/30/1985SE |
| K851375 | Tri-CountJPK · Traditional | 07/12/1985SE |
| K850096 | Laser-GlobinGKR · Traditional | 03/29/1985SE |
| K850095 | Laser-DilGIF · Traditional | 03/29/1985SE |
| K850094 | Laser-Globin PowderGKR · Traditional | 03/29/1985SE |
| K844708 | Tri-Count CalibratorKSA · Traditional | 03/05/1985SE |
| K843485 | Tri-Count LaserJPK · Traditional | 12/12/1984SE |
| K834371 | Tri-Count 10JPK · Traditional | 03/09/1984SE |
| K833130 | Tri-Count 7JPK · Traditional | 10/20/1983SE |
| K831306 | HemacalKRZ · Traditional | 06/16/1983SE |
Questions and answers
When was Laser-Lyse cleared by the FDA?
Laser-Lyse (K850097) received a 510(k) decision of Substantially Equivalent on March 29, 1985, 77 days after the submission was received.
What is the product code of K850097?
The FDA product code is GGK – Products, Red-Cell Lysing Products, a Class I (low risk) device regulated under 21 CFR 864.8540.