Lyse-Tec
FDA 510(k) K840289 · Medilab Corp.
510(k) numberK840289
Submission
- Device name
- Lyse-Tec
- Applicant
- Medilab Corp.
Mchenry, IL, US - Received
- January 24, 1984
- Decision date
- March 5, 1984
- 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 |
|---|---|---|
| K841863 | Mono-TecKTN · Traditional | 06/13/1984SE |
| K841862 | Immu-TecDCK · Traditional | 06/13/1984SE |
| K840291 | MCS Albumin ReagentCIX · Traditional | 03/30/1984SE |
| K840290 | MCS Total Protein ReagentCEK · Traditional | 03/30/1984SE |
| K832918 | Pregna-TecJHJ · Traditional | 11/03/1983SE |
| K832527 | Pregna-TecJHJ · Traditional | 09/12/1983SE |
Questions and answers
When was Lyse-Tec cleared by the FDA?
Lyse-Tec (K840289) received a 510(k) decision of Substantially Equivalent on March 5, 1984, 41 days after the submission was received.
What is the product code of K840289?
The FDA product code is GGK – Products, Red-Cell Lysing Products, a Class I (low risk) device regulated under 21 CFR 864.8540.