Sera-Pak Total Protein Reagent
FDA 510(k) K802742 · Miles Laboratories, Inc.
510(k) numberK802742
Submission
- Device name
- Sera-Pak Total Protein Reagent
- Applicant
- Miles Laboratories, Inc.
Walker, MI, US - Received
- November 3, 1980
- Decision date
- December 11, 1980
- 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 |
|---|---|---|
| K880605 | Labeling Change for Cutter Pureflo Plus IV FilterFPB · Traditional | 05/26/1988SE |
| K874909 | Micro-Bumintest Reagent TabletsJIR · Traditional | 04/28/1988SE |
| K875079 | Modified Seralyzer Alt/Sgpt Reag. Strips & ModuleCKA · Traditional | 04/05/1988SE |
| K871835 | Glucometer QC Blood Meter, Ames Gluco System PrintCGA · Traditional | 12/22/1987SE |
| K872120 | Seralyzer III Blood Chemistry AnalyzerJJF · Traditional | 10/28/1987SE |
| K873304 | Clinitek Auto 2000 Reagent Cassette (Leukocytes)LJX · Traditional | 09/11/1987SE |
| K872634 | Cutter Pureflo Plus IV FilterFPB · Traditional | 08/04/1987SE |
| K870214 | Modified Saltex Reagent StripsCHK · Traditional | 06/29/1987SE |
| K870752 | Seralyzer Ldh/Total Bilirubin/Triglycerides StripsCFJ · Traditional | 04/14/1987SE |
| K865053 | Sera-Tek Microsomal Antibody TestJZO · Traditional | 02/18/1987SE |
Questions and answers
When was Sera-Pak Total Protein Reagent cleared by the FDA?
Sera-Pak Total Protein Reagent (K802742) received a 510(k) decision of Substantially Equivalent on December 11, 1980, 38 days after the submission was received.
What is the product code of K802742?
The FDA product code is GGK – Products, Red-Cell Lysing Products, a Class I (low risk) device regulated under 21 CFR 864.8540.