Thromboplatin-M with Calcium
FDA 510(k) K930212 · Sigma Diagnostics, Inc.
510(k) numberK930212
Submission
- Device name
- Thromboplatin-M with Calcium
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- January 15, 1993
- Decision date
- May 11, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GJS – Test, Time, Prothrombin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7750
- Specialty
- Hematology
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| K010158 | Thrombomax-Hs with Calcium, Model T6540GGO · Traditional | 03/22/2001SE |
| K003267 | Sigma Diagnostics Auto D-Dimer, Model CRS126-ADAP · Traditional | 03/15/2001SE |
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Questions and answers
When was Thromboplatin-M with Calcium cleared by the FDA?
Thromboplatin-M with Calcium (K930212) received a 510(k) decision of Substantially Equivalent on May 11, 1993, 116 days after the submission was received.
What is the product code of K930212?
The FDA product code is GJS – Test, Time, Prothrombin, a Class II (moderate risk) device regulated under 21 CFR 864.7750.