Cymet-Plus
FDA 510(k) K771716 · J.T. Baker Chemical Co.
510(k) numberK771716
Submission
- Device name
- Cymet-Plus
- Applicant
- J.T. Baker Chemical Co.
Mchenry, IL, US - Received
- September 12, 1977
- Decision date
- September 20, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GKK – Cyanomethemoglobin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7500
- Specialty
- Hematology
Other 510(k)s with product code GKK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K896922 | Raichem TM Hemoglobin ReagentGKK · Traditional | Reagents Applications, Inc. | 01/25/1990SE |
| K894951 | Modified Hemoglobin Reagent SetGKK · Traditional | Macomb Biotechnology, Inc. | 10/24/1989SE |
| K883992 | KVM Prepack Hematology Reagent SetGKK · Traditional | Kvm Technologies, Inc. | 10/12/1988SE |
| K821202 | Hemoglobin Reagent SetGKK · Traditional | Omega Medical Electronics | 05/24/1982SE |
| K771090 | Unipak HemoglobinGKK · Traditional | Harleco | 07/11/1977SE |
| K770803 | Hemotology Produ&Ts (5 in All)GKK · Traditional | Hycel, Inc. | 07/05/1977SE |
More from Hycel, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K803128 | Series 810 Platelet AnalyzerGKL · Traditional | 04/03/1981SE |
| K802080 | Baker Diag. Ultrarate Chloride KitJFS · Traditional | 10/10/1980SE |
| K802035 | Baker Diag. Ultrarate CO2 Reagent KitJFL · Traditional | 09/26/1980SE |
| K801909 | Lsa 290 Assay Reagents/NephelometricDEX · Traditional | 09/26/1980SE |
| K801795 | Baker Diagnostic Ultra-Rate Sodium/Pot.JGS · Traditional | 09/16/1980SE |
| K801669 | J.T. Baker ALPHA-1-ANTITRYPSIN NepheloDEM · Traditional | 09/16/1980SE |
| K801662 | J.T. Baker ALPHA-2-MACROGLOBULIN Neph.DEP · Traditional | 09/16/1980SE |
| K801661 | J.T. Baker Ceruloplasmin NephelometricDDB · Traditional | 09/16/1980SE |
| K801362 | Albumin Nephelometric AssayJQX · Traditional | 07/21/1980SE |
| K801434 | J.T. Baker Transferrin Nephelometric AssDDG · Traditional | 07/08/1980SE |
Questions and answers
When was Cymet-Plus cleared by the FDA?
Cymet-Plus (K771716) received a 510(k) decision of Substantially Equivalent on September 20, 1977, 8 days after the submission was received.
What is the product code of K771716?
The FDA product code is GKK – Cyanomethemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7500.