Adenoclone(R)-Type 40/41 Eia Diagnostic Test (48)
FDA 510(k) K881894 · Cambridge Bioscience Corp.
510(k) numberK881894
Submission
- Device name
- Adenoclone(R)-Type 40/41 Eia Diagnostic Test (48)
- Applicant
- Cambridge Bioscience Corp.
Worcester, MA, US - Received
- May 5, 1988
- Decision date
- July 8, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GOD – Antigens, Cf (Including Cf Control), Adenovirus 1-33
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3020
- Specialty
- Microbiology
Other 510(k)s with product code GOD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K110722 | RPS Adeno Detector PlusGOD · Traditional | Rapid Pathogen Screening, Inc. | 05/17/2011SE |
| K052092 | RPS Adeno DetectorGOD · Traditional | Rapid Pathogen Screening | 11/22/2005SE |
| K990630 | SAS Adeno TestGOD · Traditional | Sa Scientific, Inc. | 08/19/1999SE |
| K972406 | Adenovirus Antigen Detection Elisa Test SystemGOD · Traditional | Immunoprobe, Inc. | 12/22/1997SE |
| K873312 | Adenoclone(Tm)-Ifa, Adenovirus Antigen TestGOD · Traditional | Cambridge Bioscience Corp. | 02/24/1988SE |
| K873082 | Adenoclone(Tm)-Eia Adenovirus Antigen TestGOD · Traditional | Cambridge Bioscience Corp. | 02/24/1988SE |
| K871229 | Antibody Assay for Detection of Adenovirus in CellGOD · Traditional | Microscan Div. Baxter Healthcare Corp. | 06/26/1987SE |
| K864645 | Adenolex (R) Latex Agglutination TestGOD · Traditional | Orion Diagnostica, Inc. | 06/04/1987SE |
| K843649 | AdenovirusGOD · Traditional | Institute Virion , Ltd. | 09/26/1985SE |
| K802929 | Adeno Virus & ControlsGOD · Traditional | Orion Diagnostica, Inc. | 12/31/1980SE |
More from Orion Diagnostica, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K890281 | Human Lyme Eia for the Detect of AntibodiesLSR · Traditional | 03/15/1989SE |
| K873312 | Adenoclone(Tm)-Ifa, Adenovirus Antigen TestGOD · Traditional | 02/24/1988SE |
| K873082 | Adenoclone(Tm)-Eia Adenovirus Antigen TestGOD · Traditional | 02/24/1988SE |
| K852969 | Rotaclone Rotavirus Diagnostic KitLIQ · Traditional | 11/05/1985SE |
Questions and answers
When was Adenoclone(R)-Type 40/41 Eia Diagnostic Test (48) cleared by the FDA?
Adenoclone(R)-Type 40/41 Eia Diagnostic Test (48) (K881894) received a 510(k) decision of Substantially Equivalent on July 8, 1988, 64 days after the submission was received.
What is the product code of K881894?
The FDA product code is GOD – Antigens, Cf (Including Cf Control), Adenovirus 1-33, a Class I (low risk) device regulated under 21 CFR 866.3020.