Buffer, Collagen Reagent and Diluent
FDA 510(k) K781710 · Diagnostica, Inc.
510(k) numberK781710
Submission
- Device name
- Buffer, Collagen Reagent and Diluent
- Applicant
- Diagnostica, Inc.
Mchenry, IL, US - Received
- October 5, 1978
- Decision date
- October 24, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JBX – Aggregrometer, Platelet
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.6675
- Specialty
- Hematology
Other 510(k)s with product code JBX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K932566 | Aggro/Link Control SoftwareJBX · Traditional | Chrono-Log Corp. | 11/02/1993SE |
| K912774 | Arachidonic AcidJBX · Traditional | Helena Laboratories | 08/22/1991SE |
| K881829 | Pat Platelet Aggregation TestJBX · Traditional | Streck Laboratories, Inc. | 07/01/1988SE |
| K862775 | Asserachrom B-Tg KitJBX · Traditional | American Bioproducts Co. | 10/22/1986SE |
| K851025 | Aggro/Link Computer InterfaceJBX · Traditional | Chrono-Log Corp. | 06/12/1985SE |
| K850592 | Platelet Aggregation ReagentJBX · Traditional | Chrono-Log Corp. | 05/13/1985SE |
| K832929 | Ristocetin Platelet Aggrega-Reagent TestJBX · Traditional | Sigma Chemical Co. | 09/29/1983SE |
| K830749 | Platelet AggregometerJBX · Traditional | Chrono-Log Corp. | 05/16/1983SE |
| K821005 | Platelet Aggregation Profiler #PAP-4JBX · Traditional | Bio/Data Corp. | 06/01/1982SE |
| K811290 | Arachidonic AcidJBX · Traditional | Bio/Data Corp. | 07/27/1981SE |
More from Bio/Data Corp.
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|---|---|---|
| K002756 | Ease-A-CultKHE · Traditional | 02/23/2001SE |
| K823348 | H. Influenza B Antisera for CieGRP · Traditional | 12/28/1982SE |
| K812434 | Diagnostic Kits & Kit ComponentsLHT · Traditional | 09/23/1981SE |
| K800398 | Paracontrol Abnormal Immunoglobulin ContDEW · Traditional | 03/12/1980SE |
| K791284 | Anti-Human Kappa SerumDFH · Traditional | 11/27/1979SE |
| K791283 | Anti-Human Lambda SerumDEH · Traditional | 11/27/1979SE |
| K791281 | Anti-Human Igg SerumDEW · Traditional | 11/27/1979SE |
| K791285 | Anti-Human GlobulinsDEW · Traditional | 10/17/1979SE |
| K791282 | Anti-Human SerumDGQ · Traditional | 10/17/1979SE |
| K790672 | Aspergillus Fumigatus, Aspergillus FlavuJWT · Traditional | 05/31/1979SE |
Questions and answers
When was Buffer, Collagen Reagent and Diluent cleared by the FDA?
Buffer, Collagen Reagent and Diluent (K781710) received a 510(k) decision of Substantially Equivalent on October 24, 1978, 19 days after the submission was received.
What is the product code of K781710?
The FDA product code is JBX – Aggregrometer, Platelet, a Class II (moderate risk) device regulated under 21 CFR 864.6675.