Goose Blood in Alsever's, Citrated (Acd)
FDA 510(k) K812367 · Dutchland Laboratories, Inc.
510(k) numberK812367
Submission
- Device name
- Goose Blood in Alsever's, Citrated (Acd)
- Applicant
- Dutchland Laboratories, Inc.
Mchenry, IL, US - Received
- August 20, 1981
- Decision date
- September 9, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LHT – Staphylococcus Aureus Somatic Antigens
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3700
- Specialty
- Microbiology
Other 510(k)s with product code LHT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K874303 | Staphylase TestLHT · Traditional | Oxoid U.S.A., Inc. | 11/06/1987SE |
| K863025 | Sero-Stat R II Staphylococcus TestLHT · Traditional | Scott Laboratories, Inc. | 09/15/1986SE |
| K820683 | Staphylococcus Latex Agglutination KitLHT · Traditional | American Scientific Products | 04/14/1982SE |
| K820531 | Endo-Staph Teichoic Acid Antibody KitLHT · Traditional | Meridian Diagnostics, Inc. | 04/14/1982SE |
| K820347 | Accu-StaphLHT · Traditional | Carr-Scarborough Microbiologicals, Inc. | 03/04/1982SE |
| K812434 | Diagnostic Kits & Kit ComponentsLHT · Traditional | Diagnostica, Inc. | 09/23/1981SE |
| K812376 | Sheep Blood in Alsever's, Citr., DefibrLHT · Traditional | Dutchland Laboratories, Inc. | 09/09/1981SE |
| K812375 | Baby Chick Blood in Alsever'sLHT · Traditional | Dutchland Laboratories, Inc. | 09/09/1981SE |
| K812374 | Adult Chicken Blood in Alsever's, C., D.LHT · Traditional | Dutchland Laboratories, Inc. | 09/09/1981SE |
| K812373 | Rabbit Blood in Alsever's, Citr., DefibrLHT · Traditional | Dutchland Laboratories, Inc. | 09/09/1981SE |
More from Dutchland Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K821919 | Powdered RPMI-1634 MediumKIT · Traditional | 07/27/1982SE |
| K821918 | Powdered RPMI-1603 MediumKIT · Traditional | 07/27/1982SE |
| K821917 | Waymouth's Powder MediumKIT · Traditional | 07/27/1982SE |
| K821916 | Improved Mem-Richter's Powder Modif.KIT · Traditional | 07/27/1982SE |
| K821915 | Bme Autoclavable MediumKIT · Traditional | 07/27/1982SE |
| K821914 | Coon's F-12 Powder MediumKIT · Traditional | 07/27/1982SE |
| K821913 | Iscove's Modified Dulbecco Powder MediumKIT · Traditional | 07/27/1982SE |
| K821912 | Mccoy's Powder Medium 5A SuspensionKIT · Traditional | 07/27/1982SE |
| K821911 | S-Mem-Joklik's PowderKIT · Traditional | 07/27/1982SE |
| K820931 | Hank's 199 Powdered MediumKIT · Traditional | 04/21/1982SE |
Questions and answers
When was Goose Blood in Alsever's, Citrated (Acd) cleared by the FDA?
Goose Blood in Alsever's, Citrated (Acd) (K812367) received a 510(k) decision of Substantially Equivalent on September 9, 1981, 20 days after the submission was received.
What is the product code of K812367?
The FDA product code is LHT – Staphylococcus Aureus Somatic Antigens, a Class I (low risk) device regulated under 21 CFR 866.3700.