Hemastain Phosphate Buffer
FDA 510(k) K760487 · Geometric Data, Div. Smithkline Corp.
510(k) numberK760487
Submission
- Device name
- Hemastain Phosphate Buffer
- Applicant
- Geometric Data, Div. Smithkline Corp.
Mchenry, IL, US - Received
- August 20, 1976
- Decision date
- August 30, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KQC – Stains, Hematology
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Specialty
- Hematology
Other 510(k)s with product code KQC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K882873 | Fieldtex HematoxylinKQC · Traditional | Anatech, Ltd. | 07/28/1988SE |
| K852843 | General Diagnostics Coag-A-Mate XCKQC · Traditional | Warner-Lambert Co. | 08/13/1985SE |
| K843619 | Retic-SetKQC · Traditional | R&D Systems, Inc. | 10/30/1984SE |
| K841848 | Retic-SetKQC · Traditional | R&D Systems, Inc. | 05/31/1984SE |
| K792550 | Ponceau S Stain SetKQC · Traditional | Electrophoresis Corp. of America | 01/16/1980SE |
| K792496 | Volu-Sol NMB Reticulocyte StainKQC · Traditional | Volu Sol Medical Industries | 12/31/1979SE |
| K791007 | Stat Diff StainKQC · Traditional | Bioscientific | 08/03/1979SE |
| K760485 | Hemastain FixativeKQC · Traditional | Geometric Data, Div. Smithkline Corp. | 08/30/1976SE |
More from Geometric Data, Div. Smithkline Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K841852 | Autolyzer 800GKZ · Traditional | 09/05/1984SE |
| K811534 | HemaspinnerGKJ · Traditional | 08/18/1981SE |
| K791041 | Hematrak Abnormal RecognitionGKZ · Traditional | 09/04/1979SE |
| K791108 | Context FilterGKZ · Traditional | 07/17/1979SE |
| K790816 | Hematrak Model 480GKZ · Traditional | 07/17/1979SE |
| K790042 | Stain, Hemastain ReticGJH · Traditional | 02/15/1979SE |
| K780577 | Platelets/Cu MMGKZ · Traditional | 05/19/1978SE |
| K772139 | Re-Cell Slide RecapJOY · Traditional | 01/05/1978SE |
| K761207 | Hematrak RBC MorphologyGKZ · Traditional | 10/18/1977SE |
| K770680 | HematrakGKZ · Traditional | 07/01/1977SE |
Questions and answers
When was Hemastain Phosphate Buffer cleared by the FDA?
Hemastain Phosphate Buffer (K760487) received a 510(k) decision of Substantially Equivalent on August 30, 1976, 10 days after the submission was received.
What is the product code of K760487?
The FDA product code is KQC – Stains, Hematology, a Class I (low risk) device regulated under 21 CFR 864.1850.