Shigella I.D.
FDA 510(k) K821337 · Analytical Products, Inc.
510(k) numberK821337
Submission
- Device name
- Shigella I.D.
- Applicant
- Analytical Products, Inc.
Mchenry, IL, US - Received
- May 5, 1982
- Decision date
- May 28, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GNB – Antisera, All Types, Shigella Spp.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3660
- Specialty
- Microbiology
Other 510(k)s with product code GNB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K961537 | SAS Shigella Sonnei Form II AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/31/1996SE |
| K961559 | SAS Shigella Dysenteriae Type 9 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961558 | SAS Shigella Flexneri Type 3 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961556 | SAS Shigella Flexneri Type 1 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961554 | SAS Shigella Boydii Type 10 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961553 | SAS Shigella Dysenteriae Type 1 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961551 | SAS Shigella Dysenteriae Type 2 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961549 | SAS Shigella Flexneri Type 2 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961548 | SAS Shigella Boydii Type 15 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961547 | SAS Shigella Boydii Type 14 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
More from Sa Scientific, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K924814 | Api 20E/UNISCEPT 20EJSS · Traditional | 03/11/1993SE |
| K923684 | Api Uniscept Mic/Type 2 and 3 and Micro MicJWY · Traditional | 12/03/1992SE |
| K922926 | Api Uniscept Kb/Type 2 and 3JWY · Traditional | 10/13/1992SE |
| K901559 | Modification to Api Uniscept 20GPLQL · Traditional | 09/10/1990SE |
| K901390 | Dmac Indole ReagentJTO · Traditional | 04/16/1990SE |
| K895796 | Api Uniscept KBJWY · Traditional | 11/13/1989SE |
| K884510 | Modification Micro-MicJWY · Traditional | 11/22/1988SE |
| K884509 | Modification Mic/Api Uniscept(R)JWY · Traditional | 11/22/1988SE |
| K880598 | Modifications to Api Uniscept (R) KBJWY · Traditional | 03/23/1988SE |
| K874466 | Api Uniscept(R) Micro-Mic(R) System/Uniscept MicJWY · Traditional | 12/09/1987SE |
Questions and answers
When was Shigella I.D. cleared by the FDA?
Shigella I.D. (K821337) received a 510(k) decision of Substantially Equivalent on May 28, 1982, 23 days after the submission was received.
What is the product code of K821337?
The FDA product code is GNB – Antisera, All Types, Shigella Spp., a Class II (moderate risk) device regulated under 21 CFR 866.3660.