510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Sclavo, Inc.

Mchenry, IL, US

Sclavo, Inc. appears in FDA device records in Mchenry, IL. FDA records list 82 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
82
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

Showing 50 of 82

FDA records hold 82 510(k) clearances for Sclavo, Inc. between 1977 and 1992. The busiest year on record is 1987, with 17. The most recent is 1992, with 2.

Clearances by year, as a table
510(k) clearance decisions for Sclavo, Inc., by decision year
YearClearances
19774
19785
19791
19804
19811
19822
19835
198410
19854
198610
198717
198810
19896
19911
19922
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K914789ELISA CMV IGMLKQSubstantially Equivalent
K914852ELISA TOXO IGMLGDSubstantially Equivalent
K914420ELISA RUBELLA IGMLFXSubstantially Equivalent
K895943NORMAL AND ABNORMAL CONTROL SERAJJYSubstantially Equivalent
K895822TOTAL BILIRUBIN L.F.CIGSubstantially Equivalent
K895847CREATININE 340 (ENZYMATIC)CGXSubstantially Equivalent
K880199CHOLINESTERASE - ACETYTHIOCHOLINE SUBSTRATEDIHSubstantially Equivalent
K880049CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATEDIHSubstantially Equivalent
K873496ATYPICAL CHOLINESTERASEDIHSubstantially Equivalent
K884035SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZERJJESubstantially Equivalent
K884649TOTAL IRON BINDING CAPACITY TESTJQESubstantially Equivalent
K882325UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TESTGFOSubstantially Equivalent
K881381REAGENTS FOR TSH ASSAYJLWSubstantially Equivalent
K881214IMMPULSE T, ASSAY REAGENTSCDPSubstantially Equivalent
K881204ACP KINETIC TEST (ACID PHOSPHATASE TEST)CKBSubstantially Equivalent
K881202IRON TESTJIYSubstantially Equivalent
K880016MODIFIED CRP LATEX TESTDCKSubstantially Equivalent
K874748IMMPULSE DIGOXIN ASSAY REAGENTSLCSSubstantially Equivalent
K875081IMMPULSE T4 ASSAY REAGENTSCDXSubstantially Equivalent
K873297DIFFERENTIAL I.M. SCREENING TESTKTNSubstantially Equivalent
K873782REUMA TESTDHRSubstantially Equivalent
K870516ALBUMIN SCREEN TESTJIQSubstantially Equivalent
K873133BNP-AMYLASE TESTJFJSubstantially Equivalent
K873134UNIFAST CK-MBCGSSubstantially Equivalent
K870268DIAGNOSTIC KIT FREE T3 AND FREE T4CECSubstantially Equivalent
K873135UNIFAST GAMMA-GTJQBSubstantially Equivalent
K872537PROTHROMBIN TIME TESTGJSSubstantially Equivalent
K872030UNI-FAST LACTATE DEHYDROGENASE (LDH-L)CFJSubstantially Equivalent
K872029UNI-FAST CREATINE KINASE TEST (CK)JHSSubstantially Equivalent
K870629CALCIUM TESTCICSubstantially Equivalent
K870630CHLORIDE TESTCHJSubstantially Equivalent
K870632FAST URIC ACIDKNKSubstantially Equivalent
K870631FAST GLUCOSECGASubstantially Equivalent
K865000IMMPULSE COATED TUBE PHENOBARBITAL ASSAY REAGENTSLETSubstantially Equivalent
K864661UNIFAST CALCIUM TESTCICSubstantially Equivalent
K865102IMMPULSE COATED TUBE PHENYTOIN ASSAY REAGENTSLESSubstantially Equivalent
K864409IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTSLERSubstantially Equivalent
K863327IMMPULSE IGE ASSAY REAGENTSDGPSubstantially Equivalent
K863486POTASSIUM TESTCEJSubstantially Equivalent
K862554IMMPULSE PHENYTOIN ASSAY REAGENTLGRSubstantially Equivalent
K862528IMMPULSE PHENOBARBITAL ASSAY REAGENTSLGQSubstantially Equivalent
K862507FAST CHOLESTEROL (TOTAL CHOLESTEROL TEST)CHHSubstantially Equivalent
K862014IMMPULSE FERRITIN ASSAY REAGENTDBFSubstantially Equivalent
K860900IMMPULSE FREE ESTRIOL ASSAY REAGENTSCGISubstantially Equivalent
K860665ALPHA-AMYLASE TESTJFJSubstantially Equivalent
K854783TRIGLYCERIDE'S TEST (TRIGLI-CINET)CDTSubstantially Equivalent
K850210ISOENZYME TEST LD-1CFESubstantially Equivalent
K850213ISOCONTROL SERUM CK-MBJJTSubstantially Equivalent
K850212ISOENZYME TEST CK-MBCGSSubstantially Equivalent
K850211ISOCONTROL SERUM LD-JJTSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain