Blanking Solution HGB
FDA 510(k) K771789 · J.T. Baker Chemical Co.
510(k) numberK771789
Submission
- Device name
- Blanking Solution HGB
- Applicant
- J.T. Baker Chemical Co.
Mchenry, IL, US - Received
- September 20, 1977
- Decision date
- October 7, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GKR – System, Hemoglobin, Automated
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5620
- Specialty
- Hematology
Other 510(k)s with product code GKR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K201217 | HemoCue Hb 301 SystemGKR · Traditional | Hemocue AB | 08/04/2020SE |
| K200909 | Hemo Control (optional Add Pack Hemo Control DM)GKR · Special | Ekf-Diagnostic GmbH | 06/12/2020SE |
| K181751 | HemoCue Hb 801 SystemGKR · Traditional | Hemocue AB | 02/01/2019SE |
| K182298 | hemochroma PLUS SystemGKR · Traditional | Immunostics Inc., | 11/16/2018SE |
| K172173 | DiaSpect Tm, DiaSpect Tm CuvettesGKR · Traditional | Ekf-Diagnostic GmbH | 04/06/2018SE |
| K163465 | hemochroma PLUS SystemGKR · Traditional | Immunostics Inc., | 09/08/2017SE |
| K122553 | Mission Plus HB Hemoglobin Testing SystemGKR · Traditional | ACON Laboratories, Inc. | 08/05/2013SE |
| K121752 | Avie Total HB Test SystemGKR · Traditional | Mec Dynamics Corp | 01/07/2013SE |
| K110393 | Ekf- Diagnostic Hemo_Control Hemoglobin Measurement System; Ekf-Diagnostic Hemoglobin…GKR · Special | Ekf-Diagnostic GmbH | 03/04/2011SE |
| K090093 | Stanbio Laboratory Hemopoint H2 DM Hemoglobin Measurement SystemGKR · Special | Stanbio Laboratory | 06/10/2009SE |
More from Stanbio Laboratory
| 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 Blanking Solution HGB cleared by the FDA?
Blanking Solution HGB (K771789) received a 510(k) decision of Substantially Equivalent on October 7, 1977, 17 days after the submission was received.
What is the product code of K771789?
The FDA product code is GKR – System, Hemoglobin, Automated, a Class II (moderate risk) device regulated under 21 CFR 864.5620.