Spectro C
FDA 510(k) K872941 · Ramco Laboratories, Inc.
510(k) numberK872941
Submission
- Device name
- Spectro C
- Applicant
- Ramco Laboratories, Inc.
Houston, TX, US - Received
- July 27, 1987
- Decision date
- September 4, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GGP – Test, Qualitative And Quantitative Factor Deficiency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7290
- Specialty
- Hematology
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|---|---|---|---|
| K251440 | CRYOcheck Chromogenic Factor VIIIGGP · Traditional | Precision Biologic, Inc. | 08/25/2025SE |
| K230852 | HemosIL Chromogenic Factor IXGGP · Traditional | Instrumentation Laboratory Company | 12/13/2023SE |
| K220728 | vWF AgGGP · Traditional | Siemens Healthcare Diagnostics Products GmbH | 06/02/2023SE |
| K214002 | CRYOcheck Chromogenic Factor IXGGP · Traditional | Precision Biologic, Inc. | 12/23/2022SE |
| K223402 | HemosIL von Willebrand Factor AntigenGGP · Special | Instrumentation Laboratory CO | 12/09/2022SE |
| K200033 | HemosIL von Willebrand Factor AntigenGGP · Special | Instrumentation Laboratory CO | 08/19/2020SE |
| K193204 | Cryocheck Chromogenic Factor VIIIGGP · Traditional | Precision Biologic | 07/17/2020SE |
| K183440 | CRYOcheck FVIII Inhibitor KitGGP · Traditional | Precision Biologic, Inc. | 03/12/2019SE |
| K181525 | INNOVANCE Free PS AgGGP · Traditional | Siemens Healthcare Diagnostics Products GmbH | 09/07/2018SE |
| K133005 | Hemosil Von Willebrand Activity AssayGGP · Special | Instrumentation Laboratory CO | 03/13/2014SE |
More from Instrumentation Laboratory CO
| 510(k) | Device | Decision |
|---|---|---|
| K983107 | VfeGGP · Traditional | 10/22/1998SE |
| K981208 | TFRJNM · Traditional | 10/21/1998SE |
| K910481 | Epo-RiaGGT · Traditional | 11/29/1991SE |
| K864701 | VWF ImmunoblotGGP · Traditional | 03/30/1987SE |
| K861159 | Spectro VWFGGP · Traditional | 05/01/1986SE |
| K831470 | PTH MRCEW · Traditional | 06/22/1983SE |
| K823016 | Candida Detection SystemLHK · Traditional | 12/28/1982SE |
| K812056 | Spectro FeiritinDBF · Traditional | 08/12/1981SE |
Questions and answers
When was Spectro C cleared by the FDA?
Spectro C (K872941) received a 510(k) decision of Substantially Equivalent on September 4, 1987, 39 days after the submission was received.
What is the product code of K872941?
The FDA product code is GGP – Test, Qualitative And Quantitative Factor Deficiency, a Class II (moderate risk) device regulated under 21 CFR 864.7290.