Ultrazyme Plus Gamma Gt-Mca #65055-65056
FDA 510(k) K830240 · Emd Chemicals, Inc.
510(k) numberK830240
Submission
- Device name
- Ultrazyme Plus Gamma Gt-Mca #65055-65056
- Applicant
- Emd Chemicals, Inc.
Gibbstown, NJ, US - Received
- January 25, 1983
- Decision date
- February 18, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JQB – Kinetic Method, Gamma-Glutamyl Transpeptidase
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1360
- Specialty
- Clinical Chemistry
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|---|---|---|---|
| K974000 | Y-Glutamyltransferase-Sl Assay , Cataloge Number 324-10, 324-30JQB · Traditional | Diagnostic Chemicals , Ltd. | 11/04/1997SE |
| K973157 | Liquid GGT (Gamma Glutamyl Transferase) Reagent SetJQB · Traditional | Pointe Scientific, Inc., | 10/10/1997SE |
| K971466 | Synchron CX Systems Gamma-Glutamyl Transferase Reagent (GGT)JQB · Traditional | Carolina Liquid Chemistries Corp. | 05/06/1997SE |
| K964457 | Roche Cobas Ibtegra Reagent CassettesJQB · Traditional | Roche Diagnostic Systems, Inc. | 01/13/1997SE |
| K964916 | Gamma-Glutamyl TranspeptidaseJQB · Traditional | Derma Media Lab., Inc. | 01/10/1997SE |
| K955770 | Gamma Glutamyl Transferase Test SystemJQB · Traditional | Abaxis, Inc. | 09/09/1996SE |
| K945800 | Y-Glutamyltransferase Assay, Catalogue Number 308-05JQB · Traditional | Diagnostic Chemicals , Ltd. | 06/09/1995SE |
| K946192 | Hichem Y-Gt Reagent KitJQB · Traditional | Hichem Diagnostics | 05/02/1995SE |
| K942962 | GGT QvetJQB · Traditional | Prisma Systems | 12/07/1994SE |
| K935984 | Glutamyl-Transferase, Procedure No. 419JQB · Traditional | Sigma Diagnostics, Inc. | 07/20/1994SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K031367 | Duopath Verotoxins Glisa TestGNA · Traditional | 01/23/2004SE |
| K990516 | Ethyl Alcohol Clinical Standard SolutionsDNN · Traditional | 03/31/1999SE |
| K981926 | Ethyl Alcohol Clinical Standard SolutionsDLJ · Traditional | 07/22/1998SE |
| K973054 | Ethyl Alcohol Clinical Standard SolutionsDNN · Traditional | 10/01/1997SE |
| K951494 | Amylase Test Item 97381/94 (R1, 97382/94 (R2-SR)CIJ · Traditional | 12/11/1995SE |
| K951750 | Glucose Test Item Number 97375/94LFR · Traditional | 09/06/1995SE |
| K950234 | Total Protein Test (Tpro) Item Number: XXXXX/R1. R2CEK · Traditional | 06/14/1995SE |
| K950128 | Total Protein Test (Tpro) Item XXXXX/R1. R2CEK · Traditional | 05/15/1995SE |
| K945322 | Phosphorus Test (Phos) Item Number 65416CEO · Traditional | 12/07/1994SE |
| K945368 | Phosphorus Test (Phos)CEO · Traditional | 12/02/1994SE |
Questions and answers
When was Ultrazyme Plus Gamma Gt-Mca #65055-65056 cleared by the FDA?
Ultrazyme Plus Gamma Gt-Mca #65055-65056 (K830240) received a 510(k) decision of Substantially Equivalent on February 18, 1983, 24 days after the submission was received.
What is the product code of K830240?
The FDA product code is JQB – Kinetic Method, Gamma-Glutamyl Transpeptidase, a Class I (low risk) device regulated under 21 CFR 862.1360.