Antibody to Varicella-Zoster Virus
FDA 510(k) K800787 · Electro-Nucleonics Laboratories, Inc.
510(k) numberK800787
Submission
- Device name
- Antibody to Varicella-Zoster Virus
- Applicant
- Electro-Nucleonics Laboratories, Inc.
Mchenry, IL, US - Received
- April 8, 1980
- Decision date
- July 14, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GGW – Test, Time, Partial Thromboplastin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7925
- Specialty
- Hematology
Other 510(k)s with product code GGW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260551 | HemosIL Factor V Leiden (APC Resistance V)GGW · Special | Instrumentation Laboratory (IL) Co. | 03/20/2026SE |
| K090105 | Lupotek KCTGGW · Traditional | R2 Diagnostics, Inc. | 12/30/2010SE |
| K083729 | Hemoclot Quanti- V-L, Factor V-L Calibrator, Biophen V-L Cal (Undiluted), Biophen Act.…GGW · Traditional | Aniara Diagnostica, LLC | 05/08/2009SE |
| K060284 | Cryocheck Clot ApcrGGW · Traditional | Precision Biologic, Inc. | 05/10/2006SE |
| K042762 | Pefakit Apc-R Factor V LeidenGGW · Traditional | Pentapharm , Ltd. | 12/22/2004SE |
| K033471 | Phospholin Es and Calcium ChlorideGGW · Traditional | R2 Diagnostics, Inc. | 02/04/2004SE |
| K992456 | Gradileiden V TestGGW · Traditional | Gradipore , Ltd. | 12/21/1999SE |
| K982062 | Cryo-Check PNP Platelet Lysate, Model PNP-10GGW · Traditional | Precision Biologicals, Inc. | 01/13/1999SE |
| K963111 | Coatest Apc (TM) Resistance V/Coatest Apc (TM) Resistance V SGGW · Traditional | Chromogenix AB | 12/23/1996SE |
| K945940 | Coatest(R) Apc(Tm) ResistanceGGW · Traditional | Axis-Shield Doc AS | 08/07/1995SE |
More from Axis-Shield Doc AS
| 510(k) | Device | Decision |
|---|---|---|
| K873925 | Virgo(Tm) Measles Igg ElisaLJB · Traditional | 02/24/1988SE |
| K873617 | Gemstar II SystemJJE · Traditional | 10/19/1987SE |
| K873416 | Multi-Access Reagent DispenserJQW · Traditional | 10/09/1987SE |
| K873358 | Gemeni Uric Acid U.V.CDO · Traditional | 09/11/1987SE |
| K873088 | Virgo(Tm) Rubella Igg ElisaLFX · Traditional | 09/09/1987SE |
| K871905 | Toxoplasma Gondii Igg ElisaLGD · Traditional | 07/30/1987SE |
| K870928 | Cholesterol (Total) Analysis ProductsCHH · Traditional | 04/22/1987SE |
| K863874 | Lipase Hydrolysis/Glycerol Kinase, TriglyceridesCDT · Traditional | 11/13/1986SE |
| K862640 | Amylase LTSCJA · Traditional | 09/09/1986SE |
| K853372 | Gemstar Ipa Theophylline Test KitKLS · Traditional | 09/04/1985SE |
Questions and answers
When was Antibody to Varicella-Zoster Virus cleared by the FDA?
Antibody to Varicella-Zoster Virus (K800787) received a 510(k) decision of Substantially Equivalent on July 14, 1980, 97 days after the submission was received.
What is the product code of K800787?
The FDA product code is GGW – Test, Time, Partial Thromboplastin, a Class II (moderate risk) device regulated under 21 CFR 864.7925.