Pharmacia Chlamydia Eia
FDA 510(k) K882676 · Pharmacia, Inc.
510(k) numberK882676
Submission
- Device name
- Pharmacia Chlamydia Eia
- Applicant
- Pharmacia, Inc.
Piscataway, NJ, US - Received
- June 28, 1988
- Decision date
- August 29, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LJC – Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3120
- Specialty
- Microbiology
Other 510(k)s with product code LJC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K032330 | CT OiaLJC · Traditional | Thermo Biostar, Inc. | 03/02/2004SE |
| K033865 | Ideia Pce ChlamydiaLJC · Special | Dakocytomation, Ltd. | 01/21/2004SE |
| K033079 | Chlamydia Igg Elisa Test SystemLJC · Traditional | Trinity Biotech USA | 11/26/2003SE |
| K982210 | Modification of Syva Microtrak II Chlamydia EiaLJC · Special | Dade Behring, Inc. | 07/09/1998SE |
| K962558 | Chlamydia Igg Elisa Test SystemLJC · Traditional | Armkel, LLC | 02/24/1997SE |
| K960850 | Access Chlamydia AssayLJC · Traditional | Bio-Rad Laboratories, Inc. | 02/04/1997SE |
| K955627 | Vidas Chlamydia Blocking AssayLJC · Traditional | Biomerieux Vitek, Inc. | 10/07/1996SE |
| K936054 | Imx Select ChlamydiaLJC · Traditional | Abbott Laboratories | 05/30/1996SE |
| K940564 | Ideia(Tm) Chlamydia Blocking Reagents, ModificationLJC · Traditional | Dako Diagnostics , Ltd. | 01/11/1996SE |
| K951010 | Chlamydia OiaLJC · Traditional | Biostar, Inc. | 10/07/1995SE |
More from Biostar, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K974350 | Allergan Immuno Cap M4, M8, K70DHB · Traditional | 02/09/1998SE |
| K972364 | Unicap PhadiatopDHB · Traditional | 09/04/1997SE |
| K972068 | Unicap Specific Ige Feia Assay, Latex Allergen Immunocap K82DHB · Traditional | 07/03/1997SE |
| K970420 | Mastercap Am 5.0/MASTERCAP RM 5.0JQW · Traditional | 06/30/1997SE |
| K964152 | Unicap Total Ige Assay/Pharmacia Total Ige Controls LMHDGC · Traditional | 04/23/1997SE |
| K962274 | Unicap 100DHB · Traditional | 09/12/1996SE |
| K941993 | Pharmacia Cap System Phadiatop FeiaDHB · Traditional | 01/30/1996SE |
| K954337 | Genotropin MixerFMF · Traditional | 11/13/1995SE |
| K951025 | Piston SyringeFMF · Traditional | 10/19/1995SE |
| K952025 | RobocapJQW · Traditional | 07/26/1995SE |
Questions and answers
When was Pharmacia Chlamydia Eia cleared by the FDA?
Pharmacia Chlamydia Eia (K882676) received a 510(k) decision of Substantially Equivalent on August 29, 1988, 62 days after the submission was received.
What is the product code of K882676?
The FDA product code is LJC – Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group), a Class I (low risk) device regulated under 21 CFR 866.3120.