Hemoglobin
FDA 510(k) K883683 · Tech-Co, Inc.
510(k) numberK883683
Submission
- Device name
- Hemoglobin
- Applicant
- Tech-Co, Inc.
Oak Park, MI, US - Received
- August 29, 1988
- Decision date
- October 6, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GJZ – Cyanomethemoglobin Reagent And Standard Solution
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7500
- Specialty
- Hematology
Other 510(k)s with product code GJZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K881242 | Cell-Dyn Rapid-Lyse and HemogloblinGJZ · Traditional | Abbott Diagnostics | 04/21/1988SE |
More from Abbott Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K921968 | In Vitro Diagnostic Reagent Set, Indir. Preg. TestJHJ · Traditional | 06/28/1996SE |
| K923376 | Visual HCG Pregnancy TestJHI · Traditional | 10/01/1992SE |
| K920766 | T4 Eia Bead AssayCDX · Traditional | 04/17/1992SE |
| K920716 | Direct Pregnancy TestJHJ · Traditional | 03/24/1992SE |
| K902574 | Potassium Reagent SetCEJ · Traditional | 07/10/1990SE |
| K901561 | Iron/Total Iron Binding CapacityJIY · Traditional | 05/17/1990SE |
| K883387 | Alanine Amino Transferase (Colorimetric Method)CKD · Traditional | 10/13/1988SE |
| K883386 | ChlorideCHJ · Traditional | 10/06/1988SE |
| K881173 | Aspartate Aminotransferase (Colorimetric Method)CIQ · Traditional | 06/07/1988SE |
| K881172 | Bilirubin (Direct)CIG · Traditional | 06/07/1988SE |
Questions and answers
When was Hemoglobin cleared by the FDA?
Hemoglobin (K883683) received a 510(k) decision of Substantially Equivalent on October 6, 1988, 38 days after the submission was received.
What is the product code of K883683?
The FDA product code is GJZ – Cyanomethemoglobin Reagent And Standard Solution, a Class II (moderate risk) device regulated under 21 CFR 864.7500.