FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
QUICK CHEM II
K Number: K901695
·
Decision May 24, 1990
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
257
Applicant Total
28
Review Days
44
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- QUICK CHEM II
- K Number
- K901695
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Seradyn, Inc.
- Date Received
- April 10, 1990
- Decision Date
- May 24, 1990
- Product Code
- JJQ
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JJQ), ordered by most recent decision date.
UBIT-IR300 INFRARED SPECTROMETRY SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DIGENE DML 2000 MICROPLATE LUMINOMETER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
STAT TRACKS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ANTHOS PHACTS VERSION MICROPLATE READER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CBI 7520 READER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Seradyn, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K070645 | SERADYN QMS TOPIRAMATE | May 17, 2007 | Substantially Equivalent |
| K062966 | QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS | Jan 12, 2007 | Substantially Equivalent |
| K062204 | ARCHITECT CORTISOL ASSAY | Sep 22, 2006 | Substantially Equivalent |
| K060998 | QMS TOBRAMYCIN | Jul 21, 2006 | Substantially Equivalent |
| K060709 | MULTIGENT GENTAMICIN | Jun 15, 2006 | Substantially Equivalent |
| K052826 | QMS QUINIDINE. QMS QUINIDINE CALIBRATORS | Dec 23, 2005 | Substantially Equivalent |
| K051211 | QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS | Nov 18, 2005 | Substantially Equivalent |
| K052815 | QMS AMIKACIN REAGENTS | Nov 1, 2005 | Substantially Equivalent |
| K050419 | QMS VANCOMYCIN | Apr 1, 2005 | Substantially Equivalent |
| K042307 | ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH) | Nov 3, 2004 | Substantially Equivalent |